BIOMET KNEE SYSTEM 141215Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304005310), received between Oct 7, 2019 and Mar 2, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

1 FDA recall record name this device's identifier.

11 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.

Recalls naming this device

1. May 18, 2018Class IITerminated

   One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial component after it has been cemented.

   Z-2177-2018 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2020Adverse 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: Cyst(s); Extraskeletal ossification; Loss of Range of Motion; Pain; Swelling; Synovitis; Unspecified Infection; Wound Dehiscence

  MAUDE report 9777507 ↗
• 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 9563404 ↗
• 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

  IT WAS REPORTED THAT APPROXIMATELY 2 YEARS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO ONGOING INFECTION OF THE L KNEE/WOUND AND DELAYED ALTERED HEALING. ALL DEVICES WERE EXPLANTED WITH A SPACED IMPLANTED. LOOSENING OF DEVICES WAS NOT IDENTIFIED DURING THE REVISION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

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

  MAUDE report 9162909 ↗

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-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-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