Biomet® Knee System 141212Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887868247774), received between Jan 27, 2020 and Sep 23, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Unsealed Device Packaging” (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.

• MalfunctionSep 23, 2021Unsealed Device Packaging; Unsealed Device Packaging

  UPON REASSESSMENT OF THE REPORTED EVENT, THIS REPORT SHOULD BE VOIDED AS NO PRODUCT OR PACKAGING FAILURE OCCURRED. REPORTED DESCRIPTION INDICATES THAT THE PRODUCT WAS OPENED DURING SURGERY AND RETURNED TO THE LOANER KIT WAREHOUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12518531 ↗
• InjuryJan 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A STUDY PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA, AS THEY WERE EXPERIENCING PAIN, STIFFNESS, AND LIMITED RANGE OF MOTION, APPROXIMATELY 1 MONTH AFTER THEIR INITIAL RIGHT TOTAL KNEE REPLACEMENT. THE PATIENT'S STATUS WAS IMPROVED AND WAS VERY SATISFIED AT THE 3 MONTH CHECK-UP.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 9632839 ↗

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