P.F.C. 86-0180Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295215578), received between Sep 13, 2019 and Sep 13, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 13, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2018, THE PATIENT UNDERWENT A THIRD RIGHT KNEE REVISION DUE TO PAIN, ARTHROFIBROSIS, DISCOMFORT, DECREASED RANGE OF MOTION, SCARRING, AND TIBIAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED A TIBIAL STRESS FRACTURE WHILE REMOVING THE TIBIAL TRAY. THE FRACTURE WAS CORRECTED WITH A SCREW AND CEMENT. TWO DEPUY CEMENT WERE USED DURING THE FIRST REVISION ON (B)(6) 2016. DOI: (B)(6) 2016 (2 DEPUY CEMENTS); (B)(6) 2018; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Discomfort; Fibrosis; Loss of Range of Motion; No Code Available; Pain; Scarring

  MAUDE report 9036603 ↗
• InjurySep 13, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2018, THE PATIENT UNDERWENT A THIRD RIGHT KNEE REVISION DUE TO PAIN, ARTHROFIBROSIS, DISCOMFORT, DECREASED RANGE OF MOTION, SCARRING, AND TIBIAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED A TIBIAL STRESS FRACTURE WHILE REMOVING THE TIBIAL TRAY. THE FRACTURE WAS CORRECTED WITH A SCREW AND CEMENT. TWO DEPUY CEMENT WERE USED DURING THE FIRST REVISION ON (B)(6) 2016. DOI: (B)(6) 2016 (2 DEPUY CEMENTS); (B)(6) 2018; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Discomfort; Fibrosis; Loss of Range of Motion; No Code Available; Pain; Scarring

  MAUDE report 9036409 ↗

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