Biomet® Knee System 141213 (UDI 00887868247781)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887868247781), received between Apr 21, 2022 and Oct 18, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (1 report).

12 other recalls cover devices cleared under the same FDA submission (K010212, K142933, K171054, K915132); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. THE PATIENT DID WELL UNTIL NEARLY A YEAR LATER WHEN THE PATIENT BEGAN TO EXPERIENCE PAIN, INSTABILITY, AUDIBLE CLICKING, AND LIMITED FLEXION DUE TO ARTHROFIBROSIS. METAL ALLERGY TESTING CONFIRMED A REACTIVITY TO NICKEL. THE SURGEON ATTRIBUTED THE PATIENT¿S INSTABILITY TO NICKEL WITHIN THE TITANIUM COMPONENTS. SUBSEQUENTLY, ONE YEAR POST-IMPLANTATION, THE PATIENT UNDERWENT OPEN INCISIONAL BIOPSY FOLLOWED BY RADICAL DEBRIDEMENT AND A REVISION OF ALL TIBIAL AND FEMORAL COMPONENTS. A COMPETITOR SYSTEM WAS IMPLANTED AND THE ORIGINAL PATELLA WAS RETAINED. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Hypersensitivity/Allergic reaction; Joint Laxity; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 17957015 ↗
• InjuryApr 21, 2022Migration; Migration

  IT WAS REPORTED VIA A CLINICAL STUDY THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, TEN MONTHS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO PAIN, STIFFNESS, SWELLING, CLICKING, AND INSTABILITY. A CT SCAN PRIOR TO THE REVISION NOTED THAT THE TIBIAL COMPONENT HAD INTERNALLY ROTATED. DURING THE PROCEDURE, THE SURGEON FOUND THAT THERE WAS CEMENT PRESENT ON THE BONE AND TIBIAL IMPLANT, WHICH WAS EASILY REMOVED. THE FEMORAL IMPLANT HAD NO CEMENT ATTACHED. THE PATELLAR COMPONENT WAS LEFT INTACT BUT ALL OTHER COMPONENTS WERE REVISED WITHOUT COMPLICATION.

  Patient problems: Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 14166363 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K010212, K142933, K171054, K915132. One submission often covers many models, so check the product and lot details in each record.

• Z-0938-2019 · Dec 21, 2018 · Terminated
  Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766
• Z-2289-2018 · May 24, 2018 · Terminated
  Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642 Product Usage: The product is intended for use in knee joint replacement arthropla
• Z-2177-2018 · May 18, 2018 · Terminated
  Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 280306 (10) 385340 Product is used in Total
• Z-2183-2018 · May 11, 2018 · Terminated
  Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.
• Z-1219-2017 · Dec 15, 2016 · Terminated
  Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 MM Item No: 32-487263, 75 MM Item No: 32-487264, and 79 MM Item No: 32-487265
• Z-1756-2015 · Apr 16, 2015 · Terminated
  MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses components include femoral, tibial, and patel
• Z-0533-2013 · Nov 15, 2012 · Terminated
  Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Product Usage: Knee joint replacement prostheses intended for application with or without bone cement. Knee joi
• Z-2104-2011 · Mar 3, 2011 · Terminated
  Biomet Interlok 75 MM fixed I-Beam Tibial Plate with locking bar CO-CR-MO/TI 6AL 4V ALLOY, REF 141224, Sterile, BIOMET ORTHOPEDICS, WARSAW. IN I-Beam Tibia Plates are knee joint
• Z-1061-2009 · Feb 13, 2009 · Terminated
  Biomet Offset Tibial Tray Adaptor, 5.0 MM, sterile, Biomet Orthopedics, Inc., Warsaw, IN, REF 141491. The Biomet Offset Tibial Tray Adaptor is a knee prosthesis intended for cemen
• Z-0706-2008 · Dec 12, 2007 · Terminated
  Biomet CC Cruciate Tibial Tray, 67 mm.; Product No. 141232, Biomet, Inc., Warsaw, IN 46581
• Z-0707-2008 · Dec 12, 2007 · Terminated
  Biomet CC Cruciate Tibial Tray, 75 mm.; Product No. 141234, Biomet, Inc., Warsaw, IN 46581
• Z-0255-2008 · Sep 18, 2007 · Terminated
  Biomet Interlok 67 mm Fixed Cruciate Tibial Plate with Locking Bar; CO-CR-MO/TI 6AL 4V Alloy; Product Number/REF 141232, Biomet Orthopedics, Inc., Warsaw, IN 46582