Vanguard Knee System CP113620Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304653559), received between Oct 1, 2019 and Oct 1, 2019 — 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 18, 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 1, 2019Unstable; Noise, Audible; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Noise, Audible; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 6 MONTHS POST IMPLANTATION OF A RIGHT TKA, THE PATIENT WAS SUFFERING FROM WEAKNESS, STIFFNESS, GAIT DEVIATION, AND PAIN. THE PATIENT WAS ALSO FURTHER EXPERIENCING PARESTHESIA, BURNING, PINS AND NEEDLES SENSATION, AND INSTABILITY IN THE AFFECTED LEG. IT IS UNKNOWN IF THE PATIENT HAS HAD ANY INTERVENTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Burning Sensation; Limited Mobility Of The Implanted Joint; Pain; Swelling; Tingling

  MAUDE report 9139208 ↗

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.