P.F.C. SIGMA 95-1015Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295230250), received between Jul 7, 2020 and Jul 7, 2020 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2020Loss of Osseointegration; Naturally Worn; Loss of Osseointegration; Naturally Worn

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2008 VIA TKA. IN JUNE 2020, THE PATIENT COMPLAINED OF A MALFUNCTION. ON (B)(6) 2020, THE REVISION SURGERY WAS PERFORMED BY REPLACING THE TIBIAL TRAY (P/N: 129433115) AND THE TIBIAL INSERT (P/N: 951015). THE SURGEON REPLACED NATURAL PATELLA WITH A PATELLA COMPONENT. DURING THE SURGERY, THE SURGEON CONFIRMED THE WEAR OF THE TIBIAL INSERT AND THE LOOSENING OF THE TIBIAL TRAY. THE FEMORAL COMPONENT WAS NOT LOOSENED. A LITTLE WEAR WAS SEEMED AT THE EXPLANTED TIBIAL TRAY¿S SURFACE, AND THE SURGEON CHECKED DAMAGE LEVEL OF THE IMPLANTS, HE JUDGED THAT THERE WAS NO COMPLAINT ABOUT THE IMPLANTS. THE REVISION SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 10240398 ↗