P.F.C. SIGMA 86-6027Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295216827), received between Oct 20, 2020 and Oct 20, 2020 — classified as 1 injury.

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

7 other recalls cover devices cleared under the same FDA submission (K241000, 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.

• InjuryOct 20, 2020Migration; Migration

  THE PRIMARY SURGERY WAS PERFORMED VIA TKA ON (B)(6) 2011. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020. THE SURGEON FOUND THAT THE SCREW OF THE EXPLANTED FEMORAL STEM¿S PART LOOSENED AND VERY WORE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10705313 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K241000, 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-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.
• Z-1317-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 3, 15.0 mm; Ref 97-0353.