Biomet® Knee System 141205Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00880304009738), received between Oct 7, 2019 and Jun 24, 2026 — classified as 13 injuries, 1 malfunction.

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

12 other recalls cover devices cleared under the same FDA submission (K063732, K102580, K171054, K912245, 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. SUBSEQUENTLY, THE PATIENT DEVELOPED PAIN AND WAS REVISED APPROXIMATELY 6 YEARS POST-OP. THE SURGEON NOTED THAT THE POLY APPEARED TO HAVE DISLODGED OR MOVED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 25611921 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Ambulation or Postural Difficulties; Extraskeletal ossification; Joint Laxity; Loss of Range of Motion; Muscle/Tendon Damage; Pain; Swelling/ Edema

  MAUDE report 24498404 ↗
• MalfunctionOct 30, 2024Positioning Failure; Positioning Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569393 ↗
• InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INITIAL LEFT TOTAL KNEE ARTHROPLASTY PERFORMED ON AN UNKNOWN DATE WITH UNKNOWN IMPLANTS. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO INSTABILITY. APPROXIMATELY ONE YEAR AND EIGHT MONTHS POST REVISION , THE PATIENT WAS REVISED AGAIN DUE TO PAIN. DURING THE REVISION THE TIBIAL BASEPLATE WAS FOUND TO BE GROSSLY LOOSE WITH THE IMPLANT DELAMINATED FROM THE UNDERLYING COBALT CEMENT AS WELL AS VARUS ANGULATION OF THE TIBIA SECONDARY TO PROGRESSIVE REMODELING OF THE PROXIMAL TIBIAL. IT WAS DETERMINED THAT THE PATIENT WOULD NEED A COMPLETE REVISION. ALL COMPONENTS WERE EXPLANTED WITHOUT COMPLICATIONS.

  Patient problems: Extraskeletal ossification; Loss of Range of Motion; Pain

  MAUDE report 18021926 ↗
• 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 17728597 ↗
• 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 17728570 ↗
• InjuryJan 12, 2022Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE TWO YEARS POST IMPLANTATION DUE TO FRACTURED LOCKING BAR. PRIOR TO SURGERY X-RAY SHOWED DISLODGED LOCKING BAR. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 13236935 ↗
• InjuryJul 6, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING PAIN, SWELLING AND A POSITIVE VANADIUM ALLERGY. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE, BUT THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: Hypersensitivity/Allergic reaction; Pain; Swelling/ Edema

  MAUDE report 12121525 ↗
• InjuryApr 23, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Insufficient Information

  MAUDE report 11715848 ↗
• 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 10374852 ↗
• InjuryJul 13, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: No Code Available

  MAUDE report 10265067 ↗
• InjuryJan 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 5 MONTHS POST REVISION, THE PATIENT HAS CONTINUED TO HAVE PAIN AND DIFFICULTY WITH AMBULATION INTERFERING WITH DAILY LIFE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 9652496 ↗
• 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 9563402 ↗
• InjuryOct 7, 2019Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Edema; Impaired Healing; Numbness; Pain; Scar Tissue; Swelling; Unspecified Infection

  MAUDE report 9163031 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063732, K102580, K171054, K912245, K915132. One submission often covers many models, so check the product and lot details in each record.

• Z-0627-2021 · Nov 25, 2020 · Terminated
  RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534, 103535 - Product Usage: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthe
• Z-1086-2019 · Mar 1, 2019 · Terminated
  Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium. Accessory to total hip implant Item Number: 103531 Product Usage: Accessory to total hip implant
• Z-1087-2019 · Mar 1, 2019 · Terminated
  Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile Titanium, Accessory to total hip implant Item Number: 103533 Product Usage: Accessory to total hip implant
• 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