VANGUARD KNEE SYSTEM 184792Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304555679), received between Jun 17, 2020 and Jun 17, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incomplete or Missing Packaging” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K110362, 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 16, 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.

• MalfunctionJun 17, 2020Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT DURING A KNEE REVISION, THE IMPLANT PACKAGING WAS OPENED AND THE IMPLANT WAS FOUND TO ONLY BE VACUUM SEALED. THE INNER PACKAGING STERILE BARRIER WAS MISSING. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10162075 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110362, 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.