P.F.C. SIGMA 86-4176Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295216384), received between Sep 11, 2018 and Sep 11, 2018 — classified as 1 injury.

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

7 other recalls cover devices cleared under the same FDA submission (K961685); 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.

• InjurySep 11, 2018Loss of Osseointegration; Loss of Osseointegration

  THE PRIMARY SURGERY PERFORMED ON (B)(6) 2007. IT WAS REPORTED THAT THE SURGEON RECOGNIZED THAT ARTHRITIS ON THE PATIENT'S LEFT KNEE, AND THE IMPLANTS WERE LOOSENED ON (B)(6) 2018. THEN, THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2018. THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: Not Applicable

  MAUDE report 7864379 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K961685. One submission often covers many models, so check the product and lot details in each record.

• Z-0057-2007 · Sep 14, 2006 · Terminated
  Depuy PFC Oval Dome Patella (Part Number 960100)3-Peg, 32 mm, sterile; REF 96-0100.
• Z-1316-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 3, 12.5 mm; Ref 97-0352.
• Z-1320-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 5, 15.0 mm; Ref 97-0373.
• Z-1315-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 2.5, 8 mm; Ref 97-0340.
• Z-1317-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 3, 15.0 mm; Ref 97-0353.
• Z-1319-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 5, 10.0 Ref 97-0371.
• Z-1318-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 4, 10 mm; Ref 97-0361.