P.F.C. SIGMA 96-2032Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295240754), received between Dec 7, 2017 and Nov 4, 2025 — classified as 21 injuries.

The most frequently reported specific device problem is “Naturally Worn” (4 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. DARTHMOUTH 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 INSTABILITY AND PAIN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23463774 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A SIGMA CR ROTATING PLATFORM TOTAL KNEE DONE PREVIOUSLY. ORIGINAL SURGERY DATE WAS UNKNOWN. PATIENT WAS BEING REVISED DUE TO INSTABILITY. THE DOCTOR REMOVED THE TIBIAL INSERT, TRIALED A THICKER OPTION AND IMPLANTED A SIZE 3 - 15MM CR RP INSERT. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23348233 ↗
• InjuryDec 4, 2024Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE RELATION OF INSTABILITY TO THE POLYETHYLENE WEAR WAS INITIALLY UNCLEAR BUT THERE WAS A SIGNIFICANT POLY WEAR ON THE POSTERIOR MEDIAL LIP OF THE POLY. NO REPORTED DELAYS IN SURGERY.

  Patient problems: Joint Laxity

  MAUDE report 20845722 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF SIGMA ROTATING PLATFORM CR KNEE FOR INSTABILITY. THE TIBIA WAS DETERMINED TO BE LOOSE INTRAOPERATIVELY. LOOSE COMPONENT WAS TIBIA, LOOSENING INTERFACE WAS BONE TO CEMENT, AND THE CEMENT MANUFACTURER WAS UNKNOWN. ALL COMPONENTS WERE REMOVED IN ORDER TO PERFORM A REVISION WITH A COMPETITOR SYSTEM. THERE WAS SIGNIFICANT POLY WEAR NOTED ON THE POSTERIOR MEDIAL LIP OF THE POLY. THERE WAS NO NOTED MALPOSITION OF ANY COMPONENTS THAT LED TO THE INSTABILITY. THERE WAS NO EXCESSIVE RESECTION OF THE TIBIA OR FEMUR DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 20845193 ↗
• InjuryNov 27, 2024Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY AND THE AFFECTED SIDE WAS THE RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20795833 ↗
• InjuryJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: THE PATELLA WAS AN IMPLANT. IT WAS LEFT UNTOUCHED AND WAS DONE BY THE FIRST IMPLANTATION IN 2011. NO SURGICAL DELAYS WERE REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17423652 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE PAIN. DOI- UNKNOWN. DOR- (B)(6) 2023. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17363457 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR KNEE FLEXION INSTABILITY. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2014; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15949058 ↗
• InjuryOct 10, 2022Unintended Movement; Unintended Movement

  CLINICAL ADVERSE EVENT RECEIVED FOR HYPERMOBILITY OF THE KNEE AND SPIN OUT. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2014. DATE OF REVISION: UNK. DATE OF EVENT: (B)(6) 2022. (LEFT KNEE). TREATMENT: REVISION; INSERT WAS REMOVED.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 15568766 ↗
• InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INSTABILITY. DATE OF IMPLANT: (B)(6) 2007. DATE OF REVISION: (B)(6) 2022 (RIGHT KNEE). TREATMENT: REVISION; FEMORAL AND TIBIAL COMPONENTS WERE REMOVED.

  Patient problems: Joint Laxity; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 15500651 ↗
• InjuryAug 10, 2021Fracture; Naturally Worn; Unintended Movement; Fracture; Naturally Worn; Unintended Movement

  CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE EXTENSOR INSTABILITY : LIGAMENT RUPTURE - SUBLUXATION OF THE PATELLA WITH DISRUPTED MEDIAL RETINACULUM (SLIGHT) EVENT IS SERIOUS AND IS CONSIDERED MODERATE EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2010; DATE OF EVENT (ONSET): (B)(6) 2010; (RIGHT KNEE). REVISION OPERATIVE NOTES 05-11-2021 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO PAIN, INSTABILITY, AND FEELINGS OF POPPING AND CLICKING. UPON ENTERING THE JOINT, CLEAR FLUID, SIGNIFICANT SYNOVITIS AND PIECES OF POLYETHYLENE WERE ENCOUNTERED. THE TIBIAL POLY WAS DETERMINED TO BE FRACTURED AND WORN WITH SIGNS OF RECURRENT SUBLUXATION / SPIN-OUT. THE FEMORAL COMPONENT WAS NOTED TO HAVE MICROMOTION AND SIGNS OF EARLY LOOSENING AND THUS WAS REVISED. THE TIBIAL COMPONENT WAS ALSO REVISED WITHOUT INDICATION OF DEFICIENCY. THE PATELLA WAS LEFT INSITU. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. TREATMENT: NONE.

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

  MAUDE report 12301880 ↗
• InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR FLEXION INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2010. DATE OF EVENT: (B)(6) 2021 (RIGHT KNEE) MEDICAL RECORD REVIEW REVEALS OFFICE NOTES (B)(6) 2021 INDICATE THE PATIENT IS EXPERIENCING PAIN, INSTABILITY, AND FEELINGS OF HER KNEE CLUNKING. PHYSICAL EXAM REVEALS LAXITY AND FLEXION INSTABILITY. THE SURGEON INDICATES THAT THE CLUNK BEING FELT IS THE TIBIA SUBLUXING SLIGHTLY ON THE FEMORAL COMPONENT, NOT RELATED TO PATELLA CLUNK. THE DATABASE INDICATED THAT THE KNEE HAS NOW BEEN REVISED, ON (B)(6) 2021, TO ADDRESS INSTABILITY AND ASEPTIC LOOSENING OF THE FEMUR AT AN UNSPECIFIED INTERFACE. THE FEMUR AND TIBIAL INSERT COMPONENTS WERE REVISED--THE TIBIAL TRAY AND PATELLA WERE RETAINED.

  Patient problems: Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 11939810 ↗
• InjuryMar 2, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2009, THE PATIENT UNDERWENT A RIGHT KNEE REVISION WITH TIBIAL INSERT EXCHANGE TO ADDRESS DISLOCATION, INSTABILITY, AND CORRECTION OF PATELLA BONE FRACTURE. THE PATIENT WAS POST INFECTION AND AN IRRIGATION AND DEBRIDEMENT WAS ALSO PERFORMED. THE PATELLA FRACTURE WAS INDICATED AS HAPPENING ON THE DAY OF THE PROCEDURE DUE TO A FALL. IT IS NOTED THE PREVIOUS OPERATIVE NOTE ALSO INDICATED A PATELLA BONE FRACTURE THAT WAS NOT ADDRESSED AT THE TIME OF THE FIRST PROCEDURE. THE SURGEON INDICATED PARTIAL EXPULSION OF THE TIBIAL INSERT. THE PATELLA COMPONENT WAS WELL-FIXED AND RETAINED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS.

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

  MAUDE report 11398265 ↗
• InjuryFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY: (B)(6). CLINICAL NOTIFICATION RECEIVED FOR SURGICAL INTERVENTION OF RIGHT TOTAL KNEE TO ADDRESS INFECTION AND CHRONIC EXTENSOR MECHANISM DISRUPTION. DATE OF IMPLANTATION: (B)(6) 2008, DATE OF REVISION: (B)(6) 2009, (RIGHT KNEE). TREATMENT: I&D, SYNOVECTOMY, AND REPAIR OF EXTENSOR MECHANISM; NO PRODUCTS REVISED. FURTHER INFORMATION RECEIVED AND REVIEWED: ON (B)(6) 2008, THE PATIENT UNDERWENT A PRIMARY RIGHT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS AND MENISCUS TEAR. DEPUY PRODUCTS WERE IMPLANTED. ON (B)(6) 2009, THE PATIENT UNDERWENT A RIGHT KNEE IRRIGATION AND DEBRIDEMENT FOR INFECTION AND REPAIR OF EXTENSOR MECHANISM. THE PATIENT WAS ALSO EXPERIENCING PAIN, EDEMA, SYNOVITIS, AND WAS FEBRILE. THERE WAS A CHRONIC DISRUPTION OF THE PATELLA TENDON NOTED. THE SURGEON ALSO NOTED FIBRINOUS TISSUE. THE PATIENT HAD RECENTLY EXPERIENCED A FALL WITH INFERIOR POLE FRACTURE OF THE PATELLA BONE WITH SOME DISPLACEMENT. THERE WAS NO INDICATION OF ANY TREATMENT TO ADDRESS THE PATELLA FRACTURE AS THE SURGEON NOTED THE FRACTURE DID NOT AFFECT HER FUNCTION AT THE TIME. ALL COMPONENTS WERE WELL-FIXED. NO COMPONENTS WERE REVISED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS.

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

  MAUDE report 11346860 ↗
• InjurySep 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SIGMA LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES PAIN, INJURIES, LOOSENING OF THE IMPLANT, BONE LOSS, DECREASED RANGE OF MOTION AND DIMINISHED MOBILITY. LITIGATION DID NOT SPECIFY THE LOOSE COMPONENT AND LOOSENING INTERFACE. ON (B)(6) 2011, THE PATIENT UNDERWENT A PRIMARY LEFT KNEE ARTHROPLASTY WITH IMPLANTATION OF DEPUY PRODUCTS. THE STICKER SHEET FOR PRODUCTS IMPLANTED DURING THE PRIMARY OPERATION CAN BE FOUND ON PAGE 1015 OF THE ATTACHED MEDICAL RECORDS. THE CEMENT USED DURING THE PRIMARY OPERATION IS NOT GIVEN IN THE AVAILABLE MEDICAL RECORDS. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2017, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO PAIN, BAKER¿S CYST, STIFFNESS, DECREASED RANGE OF MOTION, FEMORAL COMPONENT LOOSENING AT AN UNKNOWN INTERFACE, AND TIBIAL TRAY MIGRATION AND LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2014. DOR: (B)(6) 2017; LEFT KNEE.

  Patient problems: Cyst(s); Injury; Limited Mobility Of The Implanted Joint; Muscular Rigidity; No Code Available; Pain

  MAUDE report 10606461 ↗
• InjuryApr 21, 2020Unintended Movement; Unintended Movement

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT KNEE TO ADDRESS SPIN-OUT. DATE OF IMPLANTATION: (B)(6) 2004; DATE OF REVISION: (B)(6) 2020; (LEFT KNEE). TREATMENT: REVISION OF FEMUR, TIBIAL TRAY, AND TIBIAL INSERT.

  Patient problems: No Code Available

  MAUDE report 9982305 ↗
• InjuryOct 7, 2019Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS PAIN, INSTABILITY AND POLY WEAR. THERE WAS SIGNIFICANT POLY WEAR ON THE RP INSERT. THE OLD POLY INSERT WAS REPLACED WITH A NEW 17.5 X 3 RP INSERT. DOI: (B)(6) 2007. DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9161960 ↗
• InjuryApr 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RECENTLY FELL. PAINFUL KNEE WAS REVISED TODAY TO A LEFT 3 PS FEMUR AND STABILIZED RP 20 MM POLY FOR STABILITY.

  Patient problems: No Code Available; Pain

  MAUDE report 8500008 ↗
• InjuryJun 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN; DOR: (B)(46 2018; RIGHT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7569502 ↗
• InjuryMay 30, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS KNEE PAIN DEVELOPED IN 2017. FEMUR AND TIBIA WAS WELL FIXED AND ALIGNED PROPERLY. INSERT WAS WORN IN POSTERIOR MEDIAL AREA. DOI: 2008; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7554084 ↗
• InjuryDec 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION OF DEPUY INSERT OCCURRED ON (B)(6) 2017 DUE TO MEDIAL EPICONDYLE OSTEOLYSIS, LARGE AREA WITH POLYWEAR. DOI: (B)(6) 2011; DOR: (B)(6) 2017; LEFT KNEE.

  Patient problems: Discomfort; Osteolysis; Pain

  MAUDE report 7096667 ↗