BIOMET KNEE SYSTEM 141314Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00880304006706), received between Jan 8, 2020 and Dec 31, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

9 other recalls cover devices cleared under the same FDA submission (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.

• InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY SEVEN YEARS SEVEN AND A HALF MONTHS POST IMPLANTATION DUE TO COLLAPSE OF THE IMPLANT ON ONE SIDE CAUSING PAIN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 23933825 ↗
• InjuryApr 7, 2025Adverse 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: Pain; Swelling/ Edema

  MAUDE report 21784214 ↗
• InjuryNov 7, 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; Hypersensitivity/Allergic reaction; Joint Laxity; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 18085157 ↗
• InjurySep 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 17710950 ↗
• InjuryApr 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT PRESENTED WITH CHRONIC PAIN THE FOLLOWING YEAR AND HAD AN ALLERGY TEST PERFORMED WHICH TESTED POSITIVE FOR METAL. THE PATIENT WAS THEN REVISED APPROXIMATELY ONE YEAR LATER AND WAS REVISED TO AN ANTI-ALLERGIC PROSTHESIS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 16794886 ↗
• 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 14166367 ↗
• InjuryAug 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT¿S LEGAL COUNSEL REPORTED PATIENT UNDERWENT LEFT KNEE ARTHROPLASTY FOUR YEARS AGO. LEGAL COUNSEL FURTHER REPORTS PATIENT UNDERWENT A REVISION PROCEDURE SIX MONTHS AGO FOR UNKNOWN REASONS.

  Patient problems: No Information

  MAUDE report 10374874 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT HAS BEEN REPORTED THAT APPROXIMATELY 5 MONTHS POST L KNEE IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE PAIN TO HIS LEFT EXTREMITY AND WAS FOUND TO HAVE A DVT. THE PATIENT CONTINUED TO SUFFER FROM FURTHER DVTS AND PE, AND EVENTUALLY DEVELOPED A HEMATOMA RELATED TO BLOOD THINNER TREATMENT FROM THE DVTS. PATIENT HAS CONTINUED TO HAVE THESE ISSUES, APPROXIMATELY 2.5 YEARS POST IMPLANTATION. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE AND NONE HAS BEEN PROVIDED.

  Patient problems: Edema; Hematoma; Numbness; Pain; Pulmonary Embolism; Swelling; Thrombosis

  MAUDE report 9563401 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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-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