P.F.C. SIGMA 96-0111Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295232667), received between Mar 16, 2018 and Nov 12, 2024 — classified as 18 injuries.

The most frequently reported specific device problem is “Naturally Worn” (7 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION OF JOINT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2019, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20662661 ↗
• InjuryMar 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RETURNED TO SURGERY FOR AN INFECTION. ALL IMPLANTS WERE REMOVED. A SPACER WAS PLACED. DOI: (B)(6) 2016. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18867258 ↗
• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TOTAL KNEE, EXPLANTED AND ANTIBIOTICS SPACER IMPLANTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2015, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16572608 ↗
• InjuryFeb 24, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT WAS REVISED DUE TO PATELLA CLUNK DEBRIDEMENT OF PATELLA SOFT TISSUES TIBIAL POLY EXCHANGE WAS PERFORMED. THERE WAS NO SURGICAL DELAY. DOI: DECEMBER (B)(6) 2016. DOR: (B)(6) 2023. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16440645 ↗
• InjuryMay 20, 2022Naturally Worn; Naturally Worn

  CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY AND TIBIA INSERT AND PATELLA POLYWEAR. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS NOT RELATED TO DEVICE AND IS RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2010. DATE OF REVISION: (B)(6) 2022. LEFT KNEE. TREATMENT: REVISION OF THE TIBIAL INSERT AND PATELLA.

  Patient problems: Joint Laxity

  MAUDE report 14461402 ↗
• InjuryOct 12, 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. SURGEON THOUGHT THERE WAS A FLEXION EXTENSION MISMATCH. DOI: UNKNOWN ; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 12616760 ↗
• InjurySep 7, 2021Loss of or Failure to Bond; Fracture; Naturally Worn; Loss of or Failure to Bond; Fracture; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE POLY WEAR WAS ON THE INSERT. THE PATELLA WAS FRACTURED SO WEAR WAS DIFFICULT TO DETERMINE.

  Patient problems: Osteolysis

  MAUDE report 12435203 ↗
• InjuryAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD 23 JUL 2021. PATIENT HAD A UNKNOWN DEPUY SIGMA SYSTEM IMPLANTED. ON (B)(6) 2019, THE PATIENT UNDERWENT A PRIMARY LEFT KNEE ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS. DEPUY PRODUCTS WERE IMPLANTED, PATELLA WAS RESURFACED, AND UNKNOWN CEMENT WAS UTILIZED. PRIMARY PRODUCT INFORMATION CAN BE FOUND ON PAGE 73 OF THE ATTACHED MEDICAL RECORDS. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2019, THE PATIENT UNDERWENT A LEFT KNEE REVISION TO ADDRESS INFECTION. AT EVALUATION VISITS PRIOR TO REVISION, THE PATIENT WAS EXPERIENCING PAIN, SWELLING, AND DECREASED RANGE OF MOTION. THE SURGEON NOTED SYNOVITIS, SOFTENING OF THE BONE, AND A SMALL ABSCESS IN THE PATELLA THAT WAS DEBRIDED. THE TIBIAL INSERT, TIBIAL TRAY, AND FEMORAL COMPONENT WERE REVISED. THERE IS NO EVIDENCE THE PATELLAR COMPONENT WAS REVISED. THE SURGEON PLACED AN ANTIBIOTIC SPACER AND THE PATIENT RECEIVED IV ANTIBIOTICS. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2019. DOR: (B)(6) 2019. LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of Range of Motion; Pain; Swelling/ Edema; Synovitis

  MAUDE report 12336159 ↗
• InjuryJun 9, 2021Naturally Worn; Naturally Worn

  PATIENT HAD A LOOSE FEMUR AND EXPERIENCED INSTABILITY. DR. REPLACED IT WITH A TC3 FEMORAL REVISION WITH A PRESS FIT STEM AND SLEEVE. SURGERY DELAY OF 75 MINUTES. PROCEDURE SUCCESSFULLY COMPLETED. PATIENT'S POLY AND PATELLA WERE WORN AND OXIDIZED. IT WAS REPLACED WITH AN AOX POLY ENCE.

  Patient problems: Joint Laxity

  MAUDE report 11968685 ↗
• InjuryFeb 8, 2021Naturally Worn; Naturally Worn

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS POLYETHYLENE WEAR AND INSTABILITY. DATE OF IMPLANTATION: (B)(6) 2004, DATE OF REVISION: (B)(6) 2020, (LEFT KNEE). TREATMENT: FEMUR, TIBIAL TRAY, AND TIBIAL INSERT REVISED.

  Patient problems: Joint Laxity

  MAUDE report 11294647 ↗
• InjuryJan 6, 2021Adverse 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 OSTEOLYSIS DATE OF IMPLANTATION: (B)(6) 1998. DATE OF REVISION: (B)(6) 2020 (RIGHT KNEE). TREATMENT: FEMUR, TIBIAL TRAY, AND TIBIAL INSERT REVISED.

  Patient problems: Osteolysis

  MAUDE report 11124601 ↗
• InjuryDec 30, 2020Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND POLY WEAR-INDUCED SYNOVITIS. THE PATIENT'S PRIMARY SIGMA FB RP KNEE COMPONENTS WERE REMOVED AND REPLACED BY ATTUNE REVISION COMPONENTS. DOI: (B)(6) 2009, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Pain; Synovitis

  MAUDE report 11093190 ↗
• InjuryNov 3, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE SURGEON DESCRIBED THE PATELLA AS DEFECTIVE. DOI: (B)(6) 2010, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10778366 ↗
• InjuryApr 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MAUDE REPORT RECEIVED. IT WAS REPORTED THAT THE PATIENT HAD HER KNEES REPLACED: RIGHT ¿UNICOMPARTMENTAL¿ KNEE ARTHROPLASTY DONE IN 2002, LEFT TOTAL KNEE ARTHROPLASTY DONE IN 2003, AND CONVERSION OF RIGHT UNICOMPARTMENTAL TO TOTAL KNEE ARTHROPLASTY DONE IN 2003. THE RIGHT KNEE IMPLANT IS A DEPUY SIGMA KNEE WITH A STABILIZED 15MM TIBIAL INSERT SZ 2.5, (93-0053-500), SIGMA NON-POROUS RIGHT SZ 3 FEMORAL (112934, 96-0111), KNEE PATELLA 35MM ROUND 3 PEG ONSET UHMWPE PFC SIGMA, 1581-25-000, MOD TIBIAL TRAY CEMENTED. THE LEFT KNEE IMPLANT IS A DEPUY SIGMA TIBIAL POLY STAB#2 10MM (1024658, 96-0110), KNEE PATELLA PFC SIGMA ROUND/DOME 3 PEG 32MM, 96-0043-500, SIGMA NONPOROUS FEMORAL LEFT SZ 3. ALL THREE ARTIFICIAL JOINTS CONSIST OF COCR COMPONENTS. SHE CONTINUOUSLY DEVELOPED AN EFFUSION OF THE RIGHT REVISED TKA. COBALT AND CHROMIUM SYNOVIAL FLUID FROM RIGHT KNEE ASPIRATION DONE 2018, AND CHROMIUM LEVEL WAS 2.0 MCG/L AND COBALT LEVEL WAS NOT DETECTED. RIGHT KNEE.

  Patient problems: Edema; No Code Available

  MAUDE report 9962552 ↗
• InjuryMar 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO FIX PATELLAR MECHANISM. POLY INSERT EXCHANGED. DOI: (B)(6) 2019. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9868726 ↗
• InjuryDec 4, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE SURGEON REPLACED PATELLA WHICH HE SAID WAS SHOWING WEAR. DOI: (B)(6) 2007; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9412052 ↗
• InjuryAug 24, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT FELL AND LANDED ON HER LEFT KNEE. X-RAY'S SHOWED A DISRUPTION IN THE PATELLA/BONE INTERFACE. UPON OPEN EXPLORATION IT WAS DETERMINED THAT THE PATELLA COMPONENT WAS FRACTURED. LOOSENING OF THE PATELLA AT THE BONE/CEMENT INTERFACE. THE SURGEON ALSO ELECTED TO EXCHANGE THE TIBIAL INSERT TO A LARGE-THICKNESS. DOI: (B)(6) 2012; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Not Applicable

  MAUDE report 7813029 ↗
• InjuryMar 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PATELLA REPLACED DUE TO PAIN. DOI: UNKNOWN DOR; (B)(6) 2018; UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 7346571 ↗