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Zimmer Biomet Comprehensive Reverse Shoulder Recall

The Food & Drug Administration has issued a Class 1 recall on the Zimmer Biomet Comprehensive Reverse Shoulder. The FDA has noted that the device has a high fracture rate. A Class I recall is the most critical type of recall issued by the FDA. Those who continue to use devices that are the subject […]

Recall on the Zimmer Biomet Comprehensive Reverse Shoulder

The Food & Drug Administration has issued a Class 1 recall on the Zimmer Biomet Comprehensive Reverse Shoulder. The FDA has noted that the device has a high fracture rate.

A Class I recall is the most critical type of recall issued by the FDA. Those who continue to use devices that are the subject of a Class I recall may suffer serious injuries or death.

The name of the product is the Comprehensive Reverse Shoulder System Humeral Tray Model 115340. The recall affects all lots containing the part number 115340. These shoulder repair devices were manufactured from August 25, 2008 to September 27, 2011. They were distributed between October 2008 and September 2015. Approximately 3,662 devices are affected by the recall.

Who Received the Comprehensive Reverse Shoulder Manufactured by Zimmer Biomet?

The Zimmer Biomet Comprehensive Reverse Shoulder is a type of shoulder replacement device. It has been used in individuals to help restore their arm movement. For example, patients with rotator cuff tears who suffer from shoulder arthritis, or individuals who have endured an ineffective shoulder joint replacement, have received these devices.

What Went Wrong with This Medical Device?

The Zimmer Biomet Comprehensive Reverse Shoulder has reportedly fractured at a higher rate than was stated in the device’s labeling. If a fracture occurs, the patient may need additional surgeries, which may result in serious complications, such as infection, the complete loss of shoulder function, or even death.

Zimmer Biomet Reverse Shoulder Litigation News

December 15, 2016 – The U.S. Food and Drug Administration announces that Zimmer Biomet recalled their “Comprehensive Reverse Shoulder Humeral Tray Model 115340 implant due to bone fracture rates.” The FDA stated that the reason for the Urgent Medical Device Recall Notice is due to “these devices are fracturing at a higher rate than is stated in the labeling. Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.”

February 4, 2016 – Denver, CO (Case No. 1:14-cv-02667-REB-NYW) – Lexis Legal News reports that Biomet, Inc., has settled a defective comprehensive reverse shoulder implant fracture lawsuit filed against them in the U.S. District Court, District of Colorado.  The plaintiff in the case was Alfonso A. Alarid.  The lawsuit filed by Mr.  Alarid alleged that Biomet’s Reverse Shoulder Medical Devices were defective and resulted in bone fractures.  Biomet, Inc. agreed to settle Mr.  Alarid’s lawsuit in the amount of $350,000 because the two shoulder replacements that Mr. Alarid received had been recalled back in 2010.  The reverse shoulder devices were recalled in 2010 due to patient complaints of “fracturing at the joint between the trunnion and the baseplate.”

Lot Numbers Affected by the Biomet Comprehensive Reverse Shoulder Humeral Recall as Provided by the FDA:
041870 041880 041890 052860 060500 070330 079900 085130 118250 118260 118270 118280 118290 118300 118340 118350 118360 118370 118380 118390 132020 132030 153330 153340 153350 153360 153370 153380 153390 153400 153410 153420 153430 159650 159660 161960 172670 215990 216000 216010 256990 257000 257010 257020 278300 278310 278320 278330 278550 278560 278580 278590 300090 300100 300110 300120 300130 300140 300150 310580 310590 310600 310610 310620 329390 349140 349150 351030 351040 367300 367310 367320 367330 367340 367350 367360 367370 367380 372290 372310 372320 385090 402880 411980 413530 415040 415050 415060 415070 415080 415090 420630 424640 424650 424660 424670 424680 424690 424700 424710 424720 424730 424740 436760 436770 440500 457900 492370 492380 492390 492400 492410 492420 492430 492440 492450 501830 551660 556800 556820 557440 557620 557840 558840 558880 558890 558900 558910 558920 561910 562430 563440 568870 569050 569060 569070 569080 569090 569100 569120 569130 569140 569150 569690 578920 595090 597740 607390 607400 607410 607420 607430 609780 613990 630660 633600 634660 634860 635190 637190 637240 641220 641350 641390 641680 648790 648800 648810 648820 648830 648860 659950 659960 659970 659980 659990 660000 660010 660020 660030 660040 668550 668560 668570 668580 668590 668600 668610 668620 668630 668970 674320 677090 677100 677110 677140 677150 677160 677170 677180 677190 677200 680720 680730 680740 680750 680760 697100 697110 697120 697130 697150 697160 697170 697180 697190 697200 704050 704810 706840 712090 715990 716200 723830 723850 723870 723880 725550 725560 725760 726590 726710 734810 745350 762930 764700 765560 765830 765870 767360 767370 771810 788670 788680 788690 791260 791270 791280 818790 839150 846190 846200 846210 846230 846240 846280 846290 846300 846310 846320 846330 848110 848120 848130 848140 848150 848160 848170 848190 848200 848210 848220 848230 848240 848250 848260 848270 848280 848290 848300 848310 848320 854210 854220 854240 854250 854260 854290 854300 854310 854320 863330 889690 908010 950390 950400 963700 974990 981260 981270

What Do I Need to Do?

If you received one of the recalled Comprehensive Reverse Shoulder devices, your medical provider should have received a notice from Zimmer Biomet, the manufacturer of the device. You should reach out to either your medical provider or Zimmer Biomet directly to confirm that your Comprehensive Reverse Shoulder is affected.

How Can an Attorney Help if I Am Affected by This Recall?

You should strongly consider meeting with a personal injury attorney who handles defective medical device claims. In a faulty medical device liability claim, a victim alleges that a medical device has caused some type of harm. In some cases, these types of claims may involve thousands of individuals from across the country—even across the world.

There are three primary types of medical device liability claims:

  • Those that involve manufacturing defects;
  • Those that involve design defects; and
  • Those that involve a failure to warn (also called marketing defects)

What Steps are Involved in a Defective Zimmer Biomet Reverse Shoulder Liability Claim?

What Steps are Involved in a Defective Zimmer Biomet Reverse Shoulder Liability Claim?To pursue a defective medical device claim against the company allegedly responsible for your injuries, you should meet with an experienced medical device liability attorney as soon as possible. Medical device liability cases might involve thousands of claims, especially if the product was used nationwide. Every medical device liability claim is different—some may result in substantial class action lawsuits, whereas others may be resolved before litigation becomes necessary. The process depends on the individual facts of the case. Medical device liability attorneys are trained in handling these cases and will know what steps need to be taken to protect your legal rights.

It is important to provide all the information you have about your claim to your attorney. For surgical devices, provide copies of any medical records you have and your medical bills (especially if you have had to undergo revision surgeries). It is also helpful to create a timeline that lays out why you were a candidate for the medical device when you had your surgery, and the issues you had after the device was implanted.

Your attorney will study the facts of your claim and will conduct more research if necessary. Your Zimmer Biomet lawsuit attorney may need to consult with experts or other professionals before pursuing the claim. Your attorney may try to settle your medical device claim for an amount that fully compensates you for your damages. However, if a settlement cannot be reached with the manufacturer, your attorney may file a lawsuit on your behalf.

If a lawsuit is filed, it does not necessarily mean that you will have to go to court. The parties will exchange evidence throughout the duration of the claim, and multiple settlement offers will likely be sent back and forth. The parties may be able to reach a settlement by their own negotiations, or they may reach one in mediation, during which a mediator assists the parties with creating a settlement agreement.

If a trial becomes inevitable, your attorney will prepare you accordingly so that you know what to expect in the courtroom. During the trial, evidence will be presented through exhibits and witness testimony. At the end of the trial, a jury decides if the manufacturer is responsible for your harm, and, if so, how much that manufacturer should pay in damages.

What Types of Damages May be Awarded in My Zimmer Biomet Reverse Shoulder Liability Claim?

In a lawsuit, damages are awarded to make a plaintiff “whole” again. Damages are awarded to claimants to compensate the claimant for the medical expenses they have incurred, as well as other sufferings they have endured.

Depending on the facts of your claim, you may be entitled to several types of damages.

These may include:

  • Medical bills
  • Lost wages
  • The cost of future medical care
  • Loss of consortium
  • The cost of making alterations to one’s home, such as wheelchair ramps
  • Pain and suffering
  • Corrective or Revision Surgery
  • Emotional distress

The sooner you consult with an experienced medical device liability attorney, the greater your chances are of obtaining favorable results. There are important deadlines in place that limit how long claimants must seek recourse through the legal system.

Contact Parker Waichman LLP Today to Discuss Your Zimmer Biomet Reverse Shoulder Injury Claim

If you received a faulty Comprehensive Reverse Shoulder from Zimmer Biomet, contact the experienced defective medical device liability attorneys at Parker Waichman LLP today to discuss your claim and your ability to obtain total monetary damages.

Our attorneys will evaluate your case and, if you retain our services, will devote our resources, experience, and skill to your financial recovery.  To receive your free consultation with our experienced legal team, call 1-800-YOURLAWYER (1-800-968-7529).

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