P.F.C. SIGMA 96-2163Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295241522), received between Jan 5, 2018 and Oct 3, 2023 — classified as 6 injuries.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LINER AND PATELLA EXCHANGE WAS DONE DUE TO INSTABILITY. LOT NUMBER FOR PATELLA NOT READABLE AND UNKNOWN. DOI- UNKNOWN, DOR- (B)(6) 2023, AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17859612 ↗
• InjuryOct 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SIGMA RP STAB IN PATIENT REPORTEDLY HAD A FLEXION CONTRACTURE PRE-OP PRIMARY. POST PRIMARY TKA FLEXION CONTRACTURE CONTINUED. THIS REVISION WAS DONE TO CORRECT THAT ISSUE 20-30 DEGREE. FEMORAL WAS REMOVED, DISTAL RESECTION MADE. TC3 FEMORAL WITH STEM IMPLANTED ALONG WITH A THINNER INSERT- 12.5MM. DOI: (B)(6) 2020. DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Contracture

  MAUDE report 12576306 ↗
• InjuryNov 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL KNEE TO ADDRESS INFECTION. DATE OF IMPLANTATION: (B)(6) 2004, DATE OF REVISION: (B)(6) 2004, (RIGHT KNEE). TREATMENT: REVISION OF TIBIAL INSERT.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10869240 ↗
• InjuryMay 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. NO SURGICAL DELAY. DOI: (B)(6) 2018. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10053352 ↗
• InjuryFeb 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SPACER WAS EXPLANTED AND A NEW ONE IMPLANTED. IT HAS BEEN IN FOR TWO YEARS AND REINFECTED. DOI: 2 YEARS. DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9681341 ↗
• InjuryJan 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2017; RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7167144 ↗