Vanguard Knee System CP113616Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304653528), received between Jan 27, 2020 and Jul 23, 2021 — classified as 2 injuries.

4 other recalls cover devices cleared under the same FDA submission (K080204, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAD A MANIPULATION UNDER ANESTHESIA DUE TO PAIN, STIFFNESS AND ARTHROFIBROSIS. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 12216714 ↗
• InjuryJan 27, 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: Limited Mobility Of The Implanted Joint; Muscular Rigidity; Pain

  MAUDE report 9632851 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080204, 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.