P.F.C. SIGMA 96-0806Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295233992), received between Jan 2, 2020 and Oct 22, 2020 — classified as 3 injuries.

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

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 10718635 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 10718630 ↗
• InjuryJan 2, 2020Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS FRACTURE AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2016; DOR: (B)(6) 2019; LEFT KNEE.

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

  MAUDE report 9538536 ↗