Vanguard® SSK Knee System 183302Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304440494), received between Nov 10, 2020 and May 31, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K042757, K171054); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 31, 2024Adverse 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: Balance Problems; Inflammation; Loss of Range of Motion; Muscle Weakness/Atrophy; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 19435782 ↗
• InjuryNov 10, 2020Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 10 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE ALL DEVICES WERE REMOVED AND PATIENT WAS WITHOUT HARDWARE FOR APPROXIMATELY ONE YEAR TO CLEAR INFECTION. THE PATIENT WAS REIMPLANTED APPROXIMATELY 3 YEARS AGO. PATIENT STATES SHE HAS HAD A (B)(6) INFECTION FOR THE PAST 3 YEARS. SHE NOTED THAT SHE HAS TO BE REVISED AGAIN AND IS POSSIBLY LOOKING AT AN AMPUTATION. SHE ALSO RELAYED THAT THE EXTRA LONG STEMS IMPLANTED ARE ROCKING IN HER BONES AND CAUSING DAMAGE TO HER BONES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bacterial Infection; Osteolysis

  MAUDE report 10819497 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042757, K171054. 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-1861-2017 · Feb 17, 2017 · Terminated
  various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Pa