BIOMET KNEE SYSTEM 11-150844Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304008502), received between May 21, 2020 and May 21, 2020 — classified as 1 injury.

7 other recalls cover devices cleared under the same FDA submission (K171054, K921182); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE PATIENT UNDERWENT IRRIGATION AND DEBRIDEMENT OF THE LEFT KNEE WITH POLYETHYLENE BEARING EXCHANGE FOUR (4) WEEKS FOLLOWING KNEE ARTHROPLASTY TO ADDRESS A BACTERIAL INFECTION WITH WOUND COMPLICATIONS. THE PATIENT SUBSEQUENTLY DEVELOPED SEPSIS, KIDNEY INJURY AND CARDIOPULMONARY COMPLICATIONS THAT RESULTED IN DEATH FROM CARDIAC ARREST. INITIAL AND REVISION OPERATIVE NOTES DID NOT IDENTIFY ANY INTRAOPERATIVE COMPLICATIONS.

  Patient problems: Death; Multiple Organ Dysfunction Syndrome; Unspecified Infection

  MAUDE report 10079121 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171054, K921182. One submission often covers many models, so check the product and lot details in each record.

• Z-2149-2020 · Apr 17, 2020 · Terminated
  Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM 155330 Knees AGC Knee S
• 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-0076-2008 · Jul 24, 2007 · Terminated
  Biomet --DCM AGC Molded Tibial Implant (12 mm x 80 mm)--Biomet Orthopedics , Interlok finish/posterior stabilized, 12 mm thick x 80 mm wide, UHMWPE/CO-CR-MO alloy, sterile; REF 15
• Z-0077-2008 · Jul 24, 2007 · Terminated
  Biomet Orthopedics DCM AGC Molded Tibial Component, 12 mm thick x 80 mm, UHMWPE/CO-CR-MO alloy, sterile; REF 155116.