Vanguard Knee System CP113642Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304653771), received between Feb 25, 2020 and Apr 21, 2022 — classified as 1 injury, 1 malfunction.

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

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.

• InjuryApr 21, 2022Unstable; Noise, Audible; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Noise, Audible; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA A CLINICAL STUDY THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, TEN MONTHS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO PAIN, STIFFNESS, SWELLING, CLICKING, AND INSTABILITY. A CT SCAN PRIOR TO THE REVISION NOTED THAT THE TIBIAL COMPONENT HAD INTERNALLY ROTATED. DURING THE PROCEDURE, THE SURGEON FOUND THAT THERE WAS CEMENT PRESENT ON THE BONE AND TIBIAL IMPLANT, WHICH WAS EASILY REMOVED. THE FEMORAL IMPLANT HAD NO CEMENT ATTACHED. THE PATELLAR COMPONENT WAS LEFT INTACT BUT ALL OTHER COMPONENTS WERE REVISED WITHOUT COMPLICATION.

  Patient problems: Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 14166365 ↗
• MalfunctionFeb 25, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Patient Involvement

  MAUDE report 9752282 ↗

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.