P.F.C. SIGMA 86-4181Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295216438), received between Jul 21, 2017 and Dec 22, 2025 — classified as 18 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (10 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PFC SIGMA STAB INS SZ3 8MM, PFC KEEL TIB TRAY CEM SZ3, PFC*SIGMA C/S NPOR FEM LT SZ 3, AND PFC*SIGMA/OV/DOME PAT 3PEG,38 WERE INVOLVED IN A REPORTED EVENT. THE PATIENT UNDERWENT PRIMARY TOTAL KNEE ARTHROPLASTY WITH THESE IMPLANTS, AND SUBSEQUENTLY REQUIRED REVISION SURGERY DUE TO LOOSENING AT THE TIBIA AND FEMUR. THE REVISION WAS COMPLETED SUCCESSFULLY USING PRODUCTS FROM ANOTHER COMPANY. ALL THREE COMPONENTS FEMORAL, TIBIAL TRAY, AND PATELLA WERE REVISED, WHILE THE TIBIAL INSERT WAS REPLACED TO ACCOMMODATE THE OTHER COMPONENTS.

  Patient problems: Insufficient Information

  MAUDE report 23863454 ↗
• InjuryMay 8, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  (B)(6) SCHOOL OF ENGINEERING AT (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO LOOSE TIBIAL COMPONENT. PAIN WAS ALSO REPORTED. THERE WAS NO CEMENT LEFT ON THE TIBIAL COMPONENT. CEMENT MFG IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 21986336 ↗
• InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF LEFT PFC SIGMA CR FIXED BEARING KNEE FOR INSTABILITY. NO INFORMATION REGARDING PRIMARY SURGERY NO INFORMATION REGARDING HOSPITAL, SURGERY DATE OR SURGEON REGARDING PRIMARY SURGERY. NO INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 15437842 ↗
• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY FOR PATELLA RESURFACING FOR PROGRESSION OF PATELLOFEMORAL PAIN WITH A PFC SIGMA FIXED BEARING TOTAL KNEE. PATELLA NOT RESURFACED AT ORIGINAL PRIMARY SURGERY. NATIVE PATELLA RESURFACED AT THIS REVISION. DOI: (B)(6) 2006; DOR: (B)(6) 2022 UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 14186137 ↗
• InjurySep 10, 2021Osseointegration Problem; Osseointegration Problem

  COMPASS CASE (B)(4) REPORTS: THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. THE DELAY IN THE CASE WAS TO CABLE THE FEMUR AFTER IMPLANTING ATTUNE REV FEMUR WITH A 30 SLEEVE AND 14X60 STEM. A SURGICAL DELAY OF 20 MINUTES. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12453214 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT KNEE TO ADDRESS PAIN AND STIFFNESS. DATE OF IMPLANTATION: (B)(6) 1994, DATE OF REVISION: (B)(6) 2021, (RIGHT KNEE). TREATMENT: REVISION OF TIBIAL TRAY AND TIBIAL INSERT.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 12160978 ↗
• InjuryFeb 22, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION TOTAL KNEE REPLACEMENT FOR LOOSENING AND INSTABILITY. PFC SIGMA PS FB TKR. NO IMPLANT DETAILS ARE AVAILABLE DUE TO RECORDS BE UNAVAILABLE DUE TO TIMEFRAME. THE ENTIRE TIBIAL COMPONENT WAS AFFECTED, NOT ONE PARTICULAR SIDE. THE KNEE WAS 20 YEARS OLD IT WAS HARD TO DETERMINE WHAT INTERFACE WAS INVOLVED. THIS WAS ASSOCIATED WITH BONE SUBSIDENCE AND COLLATERAL LIGAMENT INSTABILITY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity

  MAUDE report 11358122 ↗
• InjuryApr 22, 2020Unintended Movement; Migration; Unintended Movement; Migration

  IT WAS REPORTED THAT THE TIBIAL TRAY FELL INTO A BIT OF VARUS AND HAS LYSIS AROUND IT. FEMUR DID NOT LOOK LOOSE WHILE TIBIAL TRAY LOOKED LOOSE. POLY WEAR WAS SUSPECTED. SURGICAL FINDINGS TIBIAL WAS GROSSLY LOOSE. CEMENTLESS FEMORAL COMPONENT WORE THROUGH THE PLASTIC POLY ON POSTERIOR MEDIAL PORTION AND POLY. FEMUR WAS NOT GROSSLY LOOSE BUT DID HAVE A LARGE DISTAL MEDIAL DEFECT NECESSITATING REMOVAL. PATELLA APPEARED TO BE WELL FIXED. CEMENT MANUFACTURER COMPETITOR. DOI: (B)(6) 1996; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Osteolysis

  MAUDE report 9987754 ↗
• InjuryFeb 21, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS TIBIAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2006. DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9738863 ↗
• InjuryJan 30, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 1997; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9647833 ↗
• InjuryJan 13, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS ASEPTIC LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. THERE IS A SIGNIFICANT OSTEOLYSIS IN PROXIMAL TIBIA. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT KNEE. .

  Patient problems: No Code Available

  MAUDE report 9581997 ↗
• InjuryJul 29, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE UNKNOWN COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. SIGMA FIXED BEARING KNEE WAS EXPLANTED AND A KASM CEMENT SPACER WAS PLACED. DOI: UNKNOWN, DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8836488 ↗
• MalfunctionApr 30, 2019Unintended Movement; Unintended Movement

  CLINICAL ADVERSE EVENT RECEIVED FOR ABNORMAL X-RAYS - FEMORAL LUCENCIES, TIBIAL LATERAL LUCENCIES, TIBIAL AP LUCENCIES, SUBSIDENCE - ABNORMAL RADIOGRAPHIC EVALUATION EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY RELATED TO BOTH DEVICE AND PROCEDURE. DOI: (B)(6) 1994. DOE: (B)(6) 2019. (RIGHT KNEE).

  Patient problems: Fall; No Consequences Or Impact To Patient; Pain; Swelling

  MAUDE report 8564382 ↗
• InjuryFeb 15, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS POLY WEAR AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 2004; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 8342956 ↗
• InjurySep 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS COMPLAINING OF KNEE PAIN. DOI: (B)(6); DOR: (B)(6); RIGHT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7901365 ↗
• InjuryAug 22, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  CLINICAL NOTIFICATION RECEIVED FOR REVISION RELATED TO PAIN, STIFFNESS, AND ASEPTIC LOOSENING OF TIBIAL COMPONENT. DOI: (B)(6) 2018; DOR: (B)(6) 2018; (LEFT KNEE).

  Patient problems: Not Applicable; Pain

  MAUDE report 7804850 ↗
• InjuryNov 10, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7017748 ↗
• InjuryOct 19, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS TIBIAL LOOSENING. LOOSENING INTERFACE OCCUR AT THE IMPLANT TO CEMENT AND CEMENT TO BONE. CEMENT MANUFACTURER IS UNKNOWN. TIBIAL TRAY, INSERT AND FEMORAL COMPONENT WERE REMOVED. MBT REVISION TRAY WITH SLEEVES AND STEM AND RP SIZE 3, 10MM STABILIZE INSERT WERE IMPLANTED ON THE TIBIAL SIDE. ON THE FEMORAL SIDE, A NEW STABILIZE FEMORAL COMPONENT WITH AUGMENTS, SLEEVE AND STEM WERE IMPLANTED.

  Patient problems: No Information

  MAUDE report 6960795 ↗
• InjuryJul 21, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE, COMPETITOR CEMENT WAS USED.

  Patient problems: No Code Available

  MAUDE report 6731401 ↗