Biomet® Knee System 141233 (UDI 00887868247965)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00887868247965), received between Mar 17, 2021 and Nov 4, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Migration” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2024Malposition of Device; Malposition of Device

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Laxity; Loss of Range of Motion; Muscle/Tendon Damage; Pain

  MAUDE report 20602697 ↗
• InjuryFeb 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY TWO YEARS AND FOUR MONTHS POST IMPLANTATION DUE TO PAIN, INSTABILITY, EFFUSIONS, AND PATELLA IMPINGEMENT WITH MALALIGNMENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Joint effusion; Muscle Weakness/Atrophy; Pain

  MAUDE report 18623321 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 17728587 ↗
• InjuryOct 19, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT APPROXIMATELY ONE YEAR AGO DUE TO PAIN. THE PATIENT ALLEGES THAT THE OPERATING PHYSICIAN STATED THAT THE PATIENT'S IMPLANT HAD SHIFTED AND THE PATIENT REPORTED HAVING A SIMILAR PAIN FROM THEIR LEG TO THEIR ANKLE AND DOWN THEIR LEG AS THEY DID PRIOR TO THE SURGERY. THE PATIENT FURTHER ALLEGED THAT THEIR NEW SURGEON ADVISED THAT THE IMPLANT WAS TOO LARGE AND WOULD NEED TO BE REVISED. THE PATIENT IS SCHEDULED FOR A REVISION SURGERY; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 15635539 ↗
• InjurySep 28, 2022Migration; Migration

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY SEVEN MONTHS POST IMPLANTATION DUE TO SUBSIDENCE AND DEVICE MIGRATION. DURING SURGERY, THE PHYSICIAN ESTABLISHED THAT THE FEMORAL COMPONENT HAD NOT GROWN IN AND ALSO OBSERVED A MALROTATION OF THE TIBIAL COMPONENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 15500889 ↗
• InjuryJun 21, 2022Migration; Migration

  IT WAS REPORTED THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY USING STANDARD INSERTS. SEVEN MONTHS POST IMPLANTATION, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR PAIN REVIEW, AND THE X-RAY SHOWED THAT THE LOCKING BAR BACKED OUT, AND A PARTIAL REVISION SURGERY WAS PERFORMED 4 DAYS POST X-RAY, TO REPLACE THE SPACER AND LOCKING BAR.

  Patient problems: Failure of Implant

  MAUDE report 14758714 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A WOUND DEBRIDEMENT AND RE-SUTURING UNDER LOCAL ANESTHESIA THREE DAYS POST IMPLANTATION DUE TO PAIN AND WOUND DRESSING OOZING BLOOD. PATIENT WAS GIVEN REGULAR MEDICATION CHANGES, EXTENDED ANTIBIOTICS AND WAS CLOSELY MONITORED. THE WOUND HEALED WELL AND THE POSTOPERATIVE RECOVER WAS POSSIBLE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Pain; Wound Dehiscence

  MAUDE report 14073889 ↗
• InjuryMar 17, 2021Migration; Migration

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 6 MONTHS POST IMPLANTATION DUE TO THE LOCKING BAR BACKING OUT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 11506968 ↗

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