BIOMET KNEE SYSTEM 141233Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304001466), received between Aug 29, 2022 and Aug 28, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2025Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT IS EXPERIENCING PAIN, SWELLING, JOINT LAXITY, LOOSENING, AND MUSCLE WEAKNESS APPROXIMATELY FOUR YEARS POST IMPLANTATION. AN EXAM BY A PHYSICIAN FOUND THE KNEE TO BE WEAK AND LOOSE. A RADIOACTIVE SCAN WAS ORDERED AND COMPLETED. DAMAGE WAS FOUND IN THE KNEE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Joint Laxity; Muscle Weakness/Atrophy; Pain; Swelling/ Edema

  MAUDE report 22913554 ↗
• InjuryApr 9, 2024Fracture; Fracture

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Insufficient Information; Joint Laxity

  MAUDE report 19075123 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Ambulation or Postural Difficulties; Arthritis; Failure of Implant; Insufficient Information; Joint Contracture; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 17408417 ↗
• MalfunctionAug 29, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE STERILE PACKAGING OF THE IMPLANT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15315511 ↗

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-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