P.F.C. SIGMA 96-2043Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295240839), received between Aug 30, 2017 and Oct 13, 2023 — classified as 9 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 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.

• InjuryOct 13, 2023Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Insufficient Information

  MAUDE report 17931646 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE POLY SWAP DUE TO INFECTION OF KNEE JOINT. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2013, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14083286 ↗
• InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION OF KNEE JOINT AND LOOSE FEMUR. DOI: (B)(6) 2013. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14046263 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS PAIN. EXPLANTED 4X12.5 CR/RP TIBIAL INSERT AND 38 MM OVAL DOME PATELLA. NO LOOSENING ON FEMUR OR TIBIAL COMPONENT. I HAVE NO FURTHER INFORMATION. NO LOT NUMBERS . (B)(6) OFFICE HAS PAPER WORK FROM 2016. DOI: (B)(6) 2016. DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 12194049 ↗
• InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6)2013, THE PATIENT UNDERWENT BILATERAL KNEE ARTHROPLASTIES TO ADDRESS OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY PRODUCTS WERE IMPLANTED BILATERALLY. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2021, THE PATIENT UNDERWENT A LEFT KNEE REVISION TO ADDRESS PAIN, SWELLING, AND INSTABILITY. THE PATIENT EXPERIENCED A FALL PRIOR TO EXPERIENCING INSTABILITY. THE SURGEON INDICATED EVIDENCE OF RECURRENT BLEEDS AS THERE WAS HEMOSIDERIN STAINED SYNOVITIS WHICH WAS RESECTED. THERE WAS A LITTLE WEAR ON THE RETAINED PATELLA, BUT NO DELAMINATION. THERE WAS MENISCUS AROUND THE PATELLA THAT WAS EXCISED. THE TIBIAL INSERT WAS THE ONLY PRODUCT REVISED. THE TIBIAL INSERT, FEMORAL COMPONENT, AND PATELLAR COMPONENT WERE RETAINED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS.

  Patient problems: Fall; Hemorrhage/Blood Loss/Bleeding; Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 12010318 ↗
• InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. DOI: UNKNOWN; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9193943 ↗
• InjuryMay 8, 2018Naturally Worn; Naturally Worn

  PATIENT WAS REVISED TO ADDRESS POLY WEAR. IT WAS ALSO REPORTED THAT THE SURGEON REPLACED WITH A THICKER POLY. DOI: (B)(6) 2002; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Not Applicable

  MAUDE report 7493782 ↗
• InjuryNov 3, 2017Fracture; Naturally Worn; Fracture; Naturally Worn

  CLINICAL DER STATES THAT THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND FRACTURED DEPUY INSERT.

  Patient problems: No Code Available

  MAUDE report 6998797 ↗
• InjuryAug 30, 2017Fracture; Fracture

  IT WAS INDICATED THAT POLYETHYLENE FRACTURE OF 962043, 4X15 RP CR INSERT SECONDARY TO INSTABILITY REPLACED WITH A 4X17.5 RP CR TIBIAL INSERT. UPDATE 8-1-2017: MEDICAL RECORDS HAVE BEEN REVIEWED. OPERATIVE NOTE (B)(6) 2009 INDICATES THE PATIENT RECEIVED A RIGHT TOTAL KNEE REPLACEMENT DUE TO DEGENERATIVE JOINT DISEASE OF THE RIGHT KNEE. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATION NOTED BY THE SURGEON.

  Patient problems: Loss of Range of Motion

  MAUDE report 6830980 ↗