P.F.C. SIGMA 96-0103Recalls & reported problems

Summary

The FDA's MAUDE database contains 257 adverse event reports that list this exact device (DI 10603295232636), received between Jul 21, 2017 and Apr 9, 2026 — classified as 251 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (45 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 257 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2026Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BEGAN TO EXPERIENCE PAIN POST REV TKA PLACED ON THE ABOVE LISTED DATE. ALL COMPONENTS ARE WELL FIXED VIA XRAY AND THE KNEE IS FOUND TO BE STABLE UPON EXAM. SURGEON BELIEVES PAIN IS LIKELY FROM HIS PATELLA AS ALL COMPONENTS APPEAR STABLE AND WELL FIXED. SIGNIFICANT SCARRING IS REMOVED FROM AROUND THE WELL FIXED PATELLAR COMPONENT HOWEVER DELAMINATION OF THE IMPLANT IS NOTED. INTRAOPERATIVELY, THE SURGEON NOTES A "BUMP" IN THE PATELLA DURING ROM AND CHOSE TO REVISE THE WELL FIXED COMPONENT. BOTH FEMORAL AND TIBIAL COMPONENTS ARE WELL ALIGNED AND WELL FIXED. AFTER REVISION OF THE COMPONENT, THE "BUMP" IS NO LONGER PRESENT. NO DELAY NOR PATIENT HARM IS NOTED. DOI: (B)(6), 2014 DOR:(B)(6), 2026 AFFECTED SIDE: RIGHT.

  Patient problems: Adhesion(s); Pain

  MAUDE report 24834462 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ASEPTIC INSTABILITY. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24387697 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS WERE EXPLANTED DUE TO INFECTION. DOI- UNKNOWN. DOR- (B)(6) 2025. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24071899 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT THE SEPTIC WASHOUT WITH SPACER PLACEMENT.

  Patient problems: Sepsis

  MAUDE report 23790803 ↗
• InjuryDec 12, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE PATELLA. DOI: UNKNOWN. DOE: NOVEMBER 25, 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23790583 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS HAVING A SLIGHT INSTABILITY BILATERALLY. A PATELLA REVISION AND POLY EXCHANGE WAS PERFORMED BILATERALLY. NO DELAYS, NO ADVERSE PATIENT CONSEQUENCES. DOI- (B)(6) 2009. DOR- (B)(6) 2025. AFFECTED SIDE- RIGHT KNEE. (B)(4) AND (B)(4) ARE RELATED PC, (B)(4) IS THE MOTHER PC AND (B)(4) IS THE DAUGHTER PC. DAUGHTER PC IS CREATED TO CAPTURE IMPLANT FOR RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23730504 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAVING SLIGHT INSTABILITY BILATERALLY. PATELLA REVISION AND POLY EXCHANGE PERFORMED BILATERALLY. NO DELAYS, NO ADVERSE PATIENT CONSEQUENCES. DOI- (B)(6) 2009, DOR- (B)(6) 2025, AFFECTED SIDE- LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23730320 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A KNEE WASH OUT ( NO DEFINED ONSET POSSIBLE FROM FALL A YEAR PRIOR AND A PATELLA FX) WITH A POLY SWAP.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 22577051 ↗
• InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON DID AN INSERT EXCHANGE AND ALSO REPLACED THE PATELLA. PATIENT WAS REVISED DUE TO BONE OVERGROWTH WHICH WAS CAUSING PAIN FOR THE PATIENT. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Extraskeletal ossification; Pain

  MAUDE report 22301460 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED AS THE OLD FEMORAL IMPLANT HAD BECOME INFECTED. THERE WAS LOOSENING OF THE FEMUR AND TIBIAL IMPLANTS AT THE BONE/CEMENT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOCTOR REMOVED OLD IMPLANTS. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22072252 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED KNEE. IMPLANTS WERE REMOVED. CEMENT SPACER WAS PUT IN. THERE WAS NO SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT DOI: (B)(6) 2019. DOR: (B)(6) 2025. AFFECTED AREA: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21988178 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(4). STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR SYNOVIAL PINCH VS INFECTION / HEMARTHROSIS DEVICE RELATEDNESS: POSSIBLY. PROCEDURE RELATEDNESS: DEFINITELY NOT. DATE OF EVENT: 14/NOV/2024. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: NO INFORMATION PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Hemorrhage/Blood Loss/Bleeding; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 20778501 ↗
• InjuryNov 25, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED, THAT THE PATIENT HAD TIBIA/PATELLA/POLY REVISION, DUE TO PAIN. CEMENT MANTLE OF TIBIA DIDN'T APPEAR NORMAL ON X-RAY. PATELLA HAD DELAMINATED. MBT REVISION TIBIA WITH 13X90 STEM WAS PUT IN WITH A 5X12.5 REP CVD POLY AND A 38 PATELLA. DOI: (B)(6) 2016. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 20773573 ↗
• InjuryOct 24, 2024Naturally Worn; Naturally Worn

  PATIENT WAS REVISED DUE TO ASEPTIC TIBIAL AND FEMORAL LOOSENING. FEMORAL COMPONENT LOOSENED AT THE CEMENT TO BONE INTERFACE. TIBIA LOOSENED AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS DEPUY SYNTHES. THE TIBIA TRAY CAME OUT CLEAN UNDERNEATH. PATELLA BUTTON HAD A GASH ON THE POLY SO IT WAS ALSO REVISED. DOI: (B)(6) 2011. DOR: (B)(6) 2024. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20526138 ↗
• InjuryOct 11, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT TIBIAL POLY INSERT HAD SIGNIFICANT WEAR ON POSTERIOR MEDIAL SIDE OF THE POLY. PATELLA HAD STARTED TO DELAMINATE AND COULD NOT BE SALVAGED. DOI: UNKNOWN. DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20426901 ↗
• InjuryOct 1, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE INSERT AND PATELLA BOTH HAD POLY WEAR AND WERE REVISED. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2010. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20343899 ↗
• InjuryJun 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT POLY AND PATELLA WERE SWAPPED DUE TO WEAR. DOI: UNKNOWN . DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19482395 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(4). STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR CHRONIC INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: (B)(6) 2024. DATE OF EVENT: 02 APR 2024. (RIGHT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, TIBIAL, INSERT, AND PATELLA WERE REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 19164059 ↗
• InjuryApr 16, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO LOOSE OF FEMUR AND PATELLA. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2002. DOR: APR 5, 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19117447 ↗
• InjuryMar 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT HAD POLY SWAP AND PATELLA REVISION. DOI: (B)(6) 2005 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE ADDITIONAL EVENT INFORMATION REPORTS THE REVISION WAS DUE TO WORN POLY ¿ INSTABILITY IN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18978915 ↗
• InjuryFeb 6, 2024Naturally Worn; Naturally Worn

  SUBJECT ID: (B)(6). STUDY NO: (B)(6) . CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO POLY WEAR. DATE OF IMPLANT: (B)(6) 2008. DATE OF REVISION: (B)(6) 2024 (LEFT KNEE) . TREATMENT: INSERT AND PATELLA WERE REVISED.

  Patient problems: Insufficient Information

  MAUDE report 18649923 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: ON (B)(6) 2023, PATIENT'S LEFT KNEE WAS REVISED WITH COMPLETE EXPLANTATION OF IMPLANTS AND PLACEMENT OF AN ANTIBIOTIC LOADED SPACER (SURESPACE TIBIAL AND FEMORAL COMPONENTS, ALONG WITH 6 PACKAGES OF DEPUY 2 GENTAMYCIN CEMENT AND ADDITIONAL POWDERED VANCOMYCIN (MANUFACTURER UNSPECIFIED) FOR A TOTAL OF 12 GRAMS OF VANCOMYCIN ADDED TO DEPUY 2 CEMENT), TO ADDRESS RECURRENT CHRONIC INFECTION (ADDITIONALLY, AN UNKNOWN MANUFACTURER'S HIGH TIBIAL OSTEOTOMY STAPLE WAS ALSO REMOVED, USING A SEPARATE INCISION). EXPLANTATION OF COMPONENTS CAUSED MINIMAL TO MODERATE BONE LOSS--A NORMAL EXPECTATION OF REVISION SURGERY. THE PATIENT TOLERATED THE PROCEDURE WELL, WITH NO COMPLICATIONS. THE MEDICAL RECORDS APPEAR TO PROVIDE NO NEW INFORMATION THAT IMPACTS PRIOR PRODUCT AND CODING ASSIGNMENTS, NOR CHANGE THE EXISTING REPORTABILITY DETERMINATIONS.

  Patient problems: Unspecified Infection

  MAUDE report 18463782 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE : UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 18438642 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO OSTEOLYSIS. DATE OF IMPLANT: (B)(6) 2011 DATE OF REVISION: (B)(6) 2023 (LEFT KNEE) TREATMENT: FEMORAL COMPONENT, TIBIAL AND INSERT WERE REVISED

  Patient problems: Osteolysis

  MAUDE report 18300246 ↗
• InjuryNov 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE SURGEON STATED THE PATIENT WAS NOT SURE HOW IT HAPPENED BUT STARTED HAVING PATELLA FEMORAL PAIN. IT WAS DONE VIA XRAY THAT THE PATELLA IMPLANT APPEARED TO BE DISLODGED FROM THE REMAINING NATIVE PATELLA. ONCE THEY OPENED THE PATIENT, THEY FOUND THAT THE 3 PEGS SHEARED OFF FROM THE PATELLA. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Pain

  MAUDE report 18183951 ↗