P.F.C. 86-0186Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295215622), received between Aug 11, 2022 and Aug 11, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Osseointegration Problem” (1 report).

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.

• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  LITIGATION RECORD RECEIVED. LITIGATION ALLEGES FRACTURE BETWEEN TIBIAL STEM AND TIBIAL BASEPLATE RESULTING TO PAIN AND INFECTION. DOI: (B)(6) 2019. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: Adhesion(s); Inadequate Osseointegration; Pain; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15209107 ↗

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