P.F.C. SIGMA 96-2011Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295240570), received between Sep 13, 2017 and Aug 1, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Naturally Worn” (6 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 1, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  (B)(4) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2025. (B)(4) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: THE SIGMA FEMORAL COMPONENT, TIBIAL INSERT, AND PATELLA WERE REVISED FOR INFECTION. THE INSERT SHOWED MINOR YELLOWING.

  Patient problems: Unspecified Infection

  MAUDE report 22685625 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXERCISING AND TORE HER PCL WHICH MADE HER CURRENT IMPLANT UNSTABLE. THE FEMORAL COMPONENT WAS REMOVED AND A POSTERIOR STABILIZED FEMUR WAS IMPLANTED ALONG WITH A POSTERIOR STABILIZED POLY. THE KNEE WAS STABLE FROM FLEXION TO FULL EXTENSION. THE TIBIAL TRAY WAS STABLE AND THE PATELLA WERE STABLE SO THEY WERE LEFT INTACT. DOI- (B)(6) 2012. DOR- (B)(6) 2023. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 16378479 ↗
• InjuryJan 26, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT HAD HER LEFT KNEE REPLACED IN (B)(6). THE EXACT DATE IS UNKNOWN NOR WAS THERE AN OPERATIVE REPORT AVAILABLE. SHE CAME BECAUSE OF STABILITY AND PAIN ISSUES IN HER LEFT KNEE. X-RAYS INCITED THAT THE CONSTRUCT WAS A DEPUY SIGMA CR RP TOTAL KNEE CONSTRUCT. THE SURGEON REVISED HER LEFT KNEE AND FOUND THAT THE POLYETHYLENE RP INSERT WAS WORN OUT POSTERIOR LATERAL WHICH MAY HAVE RESULTED IN AN UNBALANCED KNEE. A SIZE 2 LEFT CR SIGMA FEMUR AND A SZ 2 X 10 CVD RP INSERT WAS EXPLANTED. A NEW SZ 2 PS FEMUR WITH A STEM EXTENSION WAS IMPLANTED WITH A SZ 2 X 10MM PS INSERT. THE LOT NUMBER INFORMATION WAS UNABLE TO BE RECORDED BECAUSE OF BONE CEMENT IN THE BACK SIDE OF FEMUR. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 16246649 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. WASH OUT PERFORMED AND POLY WAS REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 13500378 ↗
• InjuryApr 27, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED BY THE SURGEON THAT THE SIGMA RP WAS BEING REVISED FOR INSTABILITY IN FLEXION AND EXTENSION. SZ 1.5 12.5MM CR INSERT EXPLANTED. THE SURGEON SAID THE EXPLANTED POLY IMPLANT SHOWED EXCESSIVE WEAR POSTERIOR AND MEDIAL WITH SOME DELAMINATION. SZ 2 15MM CR INSERT WAS TRIALED AND THEN RE-IMPLANTED. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11732802 ↗
• InjuryDec 11, 2018Naturally Worn; Appropriate Device Problem Term/Code Not Available; Naturally Worn; Appropriate Device Problem Term/Code Not Available

  REVISION DUE TO WEAR.

  Patient problems: No Code Available

  MAUDE report 8150138 ↗
• InjuryOct 10, 2017Fracture; Naturally Worn; Fracture; Naturally Worn

  COMPLAINT DESCRIPTION: PATIENT WAS REVISED TO ADDRESS INSTABILITY. OLD INSERT WAS BROKEN AND CUSTOMER WANTED SENT TO DEPUY UPDATE REC'D 09/25/2017 - THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. THE MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT WAS ALSO EXPERIENCING PAIN. UPON REVISION, THE TIBIAL INSERT WAS NOTED HAVE MARKED WEAR ON THE POSTERIOR ASPECT. THERE WERE SEVERAL FRAGMENTS OF POLYETHYLENE IN THE POSTERIOR ASPECT OF THE KNEE THAT WERE REMOVED AS WELL. THE COMPLAINT WAS UPDATED ON: OCTOBER 09, 2017. INVESTIGATION METHOD: THE COMPLAINT SAMPLE CONSISTED OF (1) 962011 PFC SIGMARP CV TB/IN S2 10.0, LOT CODE 1955749. DEVICE EVALUATION: COMACT-693209 X-RAY IMAGE REVIEW COMACT 660504 - X-RAY IMAGES DATED (B)(6) 2017 AND (B)(6) 2017 WERE PROVIDED FOR REVIEW. THE X-RAYS IMAGES WERE REVIEWED, AND NO EVIDENCE OF IMPLANT FRACTURE, DISASSOCIATION, OR ANYTHING INDICATIVE OF A DEVICE NONCONFORMANCE WAS FOUND. DEVICE HISTORY RECORD REVIEW TIBIAL INSERT COMACT 679593 - PRODUCT CODE 962011, WORK ORDER (B)(4) WAS MANUFACTURED ON 22ND AUG 2005. 19 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. 1 PARTS WERE

  Patient problems: No Code Available; Pain

  MAUDE report 6935345 ↗
• InjurySep 29, 2017Naturally Worn; Naturally Worn

  DER STATES THAT THE PATIENT COMPLAINED OF SOME PAIN AND INSTABILITY. POLY SHOWED SIGNS OF WEAR. IT WAS ALSO INDICATED THAT POLY WAS EXCHANGED.

  Patient problems: No Code Available; Pain

  MAUDE report 6905122 ↗
• InjurySep 13, 2017Naturally Worn; Naturally Worn

  PATIENT WAS REVISED TO ADDRESS INSTABILITY. IT WAS ALSO NOTED THAT THE INSERT WAS WORN ON THE BACK POSTERIOR CORNER.

  Patient problems: Loss of Range of Motion

  MAUDE report 6861992 ↗