P.F.C. 86-0185Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295215615), received between Oct 22, 2019 and Oct 22, 2019 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K241000, K923807); 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 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS AT THE BONE TO CEMENT INTERFACE. DEPUY CEMENT MANUFACTURER WAS USED. DOI: (B)(6) 2018 (FEMUR ONLY); DOI: (B)(6) 2018; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9218698 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K241000, K923807. One submission often covers many models, so check the product and lot details in each record.

• Z-1382-04 · Jan 15, 2004 · Terminated
  P.F.C. Modular Knee System Modular Plus Tibial Wedge 10 HEMI x 8.5MM HEIGHT Product Code: 86-0178