P.F.C. SIGMA 98-6037Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295253112), received between Jan 10, 2018 and Jan 10, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryJan 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IN 2003 THE PATIENT RECEIVED BILATERAL DEPUY SIGMA TOTAL KNEE REPLACEMENTS. (B)(6) 2014 THE PATIENT WAS ADVISED BY HIS SURGEON THAT THE PFC SIGMA TOTAL KNEE REPLACEMENT SYSTEM WAS ¿CEMENTING.¿ ON (B)(6) 2014 THE PATIENT HAD A REVISION SURGERY. AT THIS TIME, IT IS UNCLEAR WHAT THE REASON FOR REVISION OR PATIENT HARM IS. IT IS ALSO UNCLEAR IF BOTH TOTAL KNEES HAVE BEEN REVISED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS WILL BE RE-ADDRESSED. UPDATE DEC 12, 2017 AND DEC 18, 2017 MEDICAL RECORDS REVIEWED. REVISION NOTES ON (B)(6) 2014 FOR THE RIGHT KNEE INDICATED THE PRESENCE OF SEVERE, GRADE III RETROFEMORAL OSTEOLYSIS INVOLVING THE DISTAL FEMUR BENEATH THE FEMORAL COMPONENT. ADDITIONALLY, IT WAS IDENTIFIED THAT THE TIBIA COMPONENT WAS LOOSE AT THE IMPLANT TO CEMENT INTERFACE. IT WAS NOTED THAT THE PATELLA COMPONENT WAS WELL-FIXED AND NOT REVISED. TIBIA, INSERT, AND PATELLA COMPONENTS ADDED AND REPORTED. COMPLAINT UPDATED ON: JAN 10, 2018.

  Patient problems: Ambulation or Postural Difficulties; Osteolysis

  MAUDE report 7179850 ↗