BIOMET KNEE SYSTEM 141231Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304231917), received between Jul 10, 2020 and Dec 9, 2024 — classified as 3 injuries.

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

10 other recalls cover devices cleared under the same FDA submission (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 20878866 ↗
• InjuryNov 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY. THE PATIENT THEN UNDERWENT A KNEE MANIPULATION UNDER ANESTHESIA SIX MONTHS LATER FOR ARTHROFIBROSIS. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY THREE YEARS POST INITIAL IMPLANTATION DUE TO PAIN, SWELLING, STIFFNESS, AND DIFFICULTY WALKING. DURING THE REVISION, ARTHROFIBROSIS, MCL AND PCL LEADING TO INSTABILITY, AND POLYETHYLENE WEAR WERE NOTED. THE TIBIAL COMPONENT, FEMORAL COMPONENT, AND ARTICULAR SURFACE WERE EXCHANGED WITHOUT DIFFICULTY. THE PATELLAR COMPONENT REMAINED INTACT AND WELL FIXED AND WAS NOT REVISED. AT 3 AND 6 MONTH POST OP VISIT PATIENT HAD INJECTIONS FOR BURSITIS AND TENDINITIS, TREATED WITH MEDICATIONS AND COMPRESSION SLEEVE.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 12771646 ↗
• InjuryJul 10, 2020Migration; Migration

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Pain

  MAUDE report 10256845 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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-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-0707-2008 · Dec 12, 2007 · Terminated
  Biomet CC Cruciate Tibial Tray, 75 mm.; Product No. 141234, Biomet, Inc., Warsaw, IN 46581
• Z-0706-2008 · Dec 12, 2007 · Terminated
  Biomet CC Cruciate Tibial Tray, 67 mm.; Product No. 141232, 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