Vanguard Knee System CP113624Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304653597), received between Aug 3, 2026 and Aug 3, 2026 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Loosening of Implant Not Related to Bone-Ingrowth

  It was reported that the patient underwent a right total knee arthroplasty and was subsequently revised approximately 18 months post-implantation due to pain, instability, and aseptic loosening. It was reported that no further information is available.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Joint Laxity; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 50120648 ↗

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.