P.F.C. SIGMA 96-2042Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10603295240822), received between Oct 6, 2017 and Apr 28, 2026 — classified as 31 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (9 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Break

  IT WAS REPORTED THAT SPRING PORTION OF 25MM DRILL BIT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25013088 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION, DUE TO WHICH THE POLY WAS SWAPPED.

  Patient problems: Unspecified Infection

  MAUDE report 25013027 ↗
• InjuryFeb 17, 2026Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POLY SWAP DUE TO PAIN IN THE KNEE. POLY CAME OUT WITH POSTERIOR MEDIAL WEAR-JUST REPLACED SAME SIZE POLY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 24364379 ↗
• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS INFECTION IN RIGHT KNEE. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24133722 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A POLY EXCHANGE DUE TO LAXITY. NO BROKEN INSTRUMENTS. NO DELAYS. NO ADVERSE EVENTS. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 22072811 ↗
• InjuryNov 1, 2023Naturally Worn; Naturally Worn

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO POLY WEAR AND SYNOVITIS. DATE OF IMPLANT: (B)(6) 2009. DATE OF REVISION: (B)(6) 2023. (LEFT KNEE). TREATMENT: INSERT AND PATELLA WERE REVISED.

  Patient problems: Synovitis

  MAUDE report 18047251 ↗
• InjuryApr 3, 2023Naturally Worn; Unintended Movement; Naturally Worn; Unintended Movement

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THE FOLLOWING: THE PATIENT SPUN OUT AGAIN WHEN HE OR SHE WAS FITTED WITH THE BRACE ON FRIDAY THE 14TH.

  Patient problems: Insufficient Information

  MAUDE report 16663241 ↗
• InjuryJan 3, 2023Fracture; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Fracture; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INSTABILITY. DATE OF IMPLANT: (B)(6) 2006. DATE OF REVISION: (B)(6) 2022. (RIGHT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, TIBIAL, INSERT, AND PATELLA WERE REVISED.

  Patient problems: Joint Laxity; Osteolysis; Synovitis

  MAUDE report 16088874 ↗
• InjuryJan 3, 2023Naturally Worn; Naturally Worn

  REVISION COMPLETED DUE TO LOOSENING OF TIBIA, FEMUR, PATELLA AT BONE TO CEMENT INTERFACE. EXACT PRIMARY SURGERY DATE IS UNKNOWN, BUT IN 2010. PATIENT IS BEING REVISED TODAY FOR ASEPTIC LOOSENING TO THE FEMORAL COMPONENT AND TIBIAL COMPONENT DUE TO POLY FAILURE AND DEBRIS RESIDUAL IN THE KNEE POST POLY FAILURE. PATIENT WAS REVISED TO A CRS CONSTRUCT. LOT NUMBER ON FEMUR AND PATELLA WERE UNABLE TO BE RETRIEVED. NO SURGICAL DELAY. DOI: (B)(6) 2010. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT.

  Patient problems: Insufficient Information

  MAUDE report 16087090 ↗
• InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: (B)(6) 2022. (LEFT KNEE). TREATMENT: REVISION (POLY EXCHANGE) AND I&D.

  Patient problems: Unspecified Infection

  MAUDE report 15418939 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INCREASE PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2022, DATE OF EVENT: (B)(6) 2022, (LEFT KNEE). TREATMENT: ASPIRATION/DRAINAGE; BLOODY, CLOUDY FLUID WAS EXTRACTED AND SENT FOR SYNOVASURE.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 15293224 ↗
• InjuryMay 26, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR FEELINGS OF POPPING AND INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS RELATED TO DEVICE AND NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2006; DATE OF EVENT: (B)(6) 2022; DATE OF REVISION: NOT SPECIFIED (RIGHT KNEE). TREATMENT: REVISION OF THE TIBIAL INSERT.

  Patient problems: Joint Laxity; Osteolysis; Swelling/ Edema

  MAUDE report 14514983 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A FALL, THE PATIENT TORE THE POSTERIOR CRUCIATE LIGAMENT AND THEREFORE HER CR PROSTHESIS WAS UNSTABLE. REVISION WAS NECESSARY TO ADDRESS THE ISSUE. DURING THE OPERATION THE SURGEON NOTICED THAT THE TIBIAL PLATEAU WAS UNSEALED AT THE INTERFACE BETWEEN THE TIBIAL PLATEAU AND THE CEMENT.

  Patient problems: Fall; Joint Laxity; Pain; Unspecified Musculoskeletal problem

  MAUDE report 13772844 ↗
• InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED OF THE REMOVAL OF TOTAL JOINT PROSTHESIS INSERTION OF ANTIBIOTIC SPACER DUE TO INFECTION. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2014; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12883431 ↗
• InjurySep 13, 2021Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. SURGEON ELECTED TO CHANGE POLY FROM 12.5 TO 17.5 AND REPLACED PATELLA. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12459902 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASE (B)(4) REPORTS: THE PATIENT WAS REVISED TO ADDRESS PAIN AND POSSIBLE INFECTION. DEPUY CEMENT WAS USED. NO DELAY IN SURGERY. DOI: (B)(6) 2015, DOR: (B)(6) 2021; RIGHT KNEE.

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

  MAUDE report 12438012 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN, INFLAMMATION, INSTABILITY AND LOOSENING OF THE TIBIA COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2011 DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Inflammation; Joint Laxity; Pain

  MAUDE report 12169677 ↗
• InjuryFeb 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT UNDERWENT A PRIMARY RIGHT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. DEPUY PRODUCTS WERE IMPLANTED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2018, THE PATIENT UNDERWENT A RIGHT KNEE REVISION WITH TIBIAL INSERT EXCHANGE TO ADDRESS INFECTION. THE SURGEON ALSO PERFORMED AN IRRIGATION AND DEBRIDEMENT, COMPLETE SYNOVECTOMY, AND PLACEMENT OF STIMULANT ANTIBIOTIC CONTAINING PELLETS. PRIOR TO REVISION, THE PATIENT WAS EXPERIENCING THE FOLLOWING ADVERSE SYMPTOMS: PAIN, DISCOMFORT, SWELLING, WARMTH, AND NUMBNESS. THE SURGEON NOTED SYNOVITIS WITHIN THE KNEE. THE TIBIAL TRAY, PATELLAR COMPONENT, AND FEMORAL COMPONENT WERE WELL-FIXED AND RETAINED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Numbness; Pain; Swelling/ Edema; Synovitis

  MAUDE report 11322744 ↗
• InjuryDec 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RECURRENT HEMARTHROSIS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND NOT RELATED TO PROCEDURE. REVISION OF INSERT WITH SYNOVECTOMY HAS OCCURRED. DOI: (B)(6) 2007. DOE: (B)(6) 2017. DOR: (B)(6) 2018; (RIGHT KNEE).

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

  MAUDE report 11036605 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S POLY INSERT WAS REVISED FOR PAIN ORIGINAL IMPLANT DATE IS UNKNOWN. DOI: UNKNOWN DOR : (B)(6) 2020 LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10816772 ↗
• InjuryJul 21, 2020Device Markings/Labelling Problem; Illegible Information; Device Markings/Labelling Problem; Illegible Information

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. THE TIBIAL TRAY AND POLY WERE REPLACED. THE LOT NUMBER ON THE POLY WAS DAMAGED AND ONLY PART OF THE NUMBER WAS LEGIBLE. DOI: (B)(6) 2007, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10303540 ↗
• InjuryMar 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY WAS USED IN ANTIBIOTIC SPACER. DOI: (B)(6) 2020. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9880210 ↗
• InjuryNov 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS KNEE PAIN AND WHAT WAS ASSUMED TO BE FEMORAL LOOSENING. THE FEMUR WAS NOT LOOSE BUT WAS REMOVED. THE INSERT AND PATELLA WERE ALSO REMOVED. THE TIBIA WAS WELL FIXED AND RETAINED. A NEW SIGMA SIZE 3 TC3 FEMUR, AUGMENTS, CEMENTED STEM, INSERT AND PATELLA WERE IMPLANTED. PATIENT HAS A SIGMA RP CR CEMENTED KNEE IMPLANTED IN 2015. DOI: (B)(6) 2015. DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9266101 ↗
• InjuryJul 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ABNORMAL X-RAYS INDICATING LYSIS AND MICROMOTION: ABNORMAL RADIOGRAPHIC EVALUATION EVENT IS SERIOUS AND IS CONSIDERED MODERATE, AND IS AWAITING REVISION EVENT IS DEFINITELY RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY THAT IT IS RELATED TO PROCEDURE. DOI: (B)(6) 2015, DOE: (B)(6) 2019, (RIGHT KNEE).

  Patient problems: Extraskeletal ossification; Muscular Rigidity; No Code Available; Osteolysis

  MAUDE report 8835778 ↗
• InjuryOct 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO OSTEOLYSIS AND PAIN. DOI: (B)(6) 2014; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: No Code Available; Osteolysis; Pain; Swelling

  MAUDE report 7995466 ↗