Vanguard Knee System CP113618Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304476844), received between Oct 18, 2023 and Oct 18, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Noise, Audible” (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.

• InjuryOct 18, 2023Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT A PATIENT UNDERWENT INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. THE PATIENT DID WELL UNTIL NEARLY A YEAR LATER WHEN THE PATIENT BEGAN TO EXPERIENCE PAIN, INSTABILITY, AUDIBLE CLICKING, AND LIMITED FLEXION DUE TO ARTHROFIBROSIS. METAL ALLERGY TESTING CONFIRMED A REACTIVITY TO NICKEL. THE SURGEON ATTRIBUTED THE PATIENT¿S INSTABILITY TO NICKEL WITHIN THE TITANIUM COMPONENTS. SUBSEQUENTLY, ONE YEAR POST-IMPLANTATION, THE PATIENT UNDERWENT OPEN INCISIONAL BIOPSY FOLLOWED BY RADICAL DEBRIDEMENT AND A REVISION OF ALL TIBIAL AND FEMORAL COMPONENTS. A COMPETITOR SYSTEM WAS IMPLANTED AND THE ORIGINAL PATELLA WAS RETAINED. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Hypersensitivity/Allergic reaction; Joint Laxity; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 17956990 ↗

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.