P.F.C. SIGMA 96-2031Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10603295240747), received between Oct 5, 2017 and Jan 22, 2026 — classified as 40 injuries.

The most frequently reported specific device problem is “Naturally Worn” (19 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 40 reports, in the reporter's own words as published by the FDA.

• InjuryJan 22, 2026Naturally Worn

  PATIENT WAS REVISED FOR PAIN AND INSTABILITY DUE TO WORN POLY. DOI: UNKNOWN . DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 24151705 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT SUFFERS FROM INSTABILITY DUE TO IMPLANT. THE SYSTEM IS OVER TEN YEARS OLD. DOI- UNKNOWN. DOR- (B)(6) 2025. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24058167 ↗
• InjuryDec 29, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE POLY WEAR ON INSERT. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23906387 ↗
• InjurySep 3, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT WAS REVISED WITH POLY WEAR SWAPPED FOR THICKER SIZE. THERE WERE NO ADVERSE CONSEQUENCES. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22951138 ↗
• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN WITH SOME PAIN IN HER KNEE. SURGEON BELIEVES THE PATIENT TO BE INFECTED BUT ONLY SUPERFICIAL. UPON OPENING THE JOINT, THA TIBIA WAS FOUND TO BE LOOSE. SURGEON REMOVED ALL IMPLANTS AND PLACED A SPACER USING AN ATTUNE RPPS POLY AND CEMENTED ATTUNE PS FEMUR UNTIL THE INFECTION CLEARS AND SURGEON CAN COME BACK TO REVISE. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22115986 ↗
• InjuryApr 2, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT SIGMA RP CR POLY WORN OUT . POLY SWAP PROCEDURE PERFORMED- WEAR WAS NOTICED POSTERIOR-MEDIAL CORNER. DOI: (B)(6) 2006. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21754128 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RIGHT KNEE WASH OUT/POLY SWAP WAS DONE. THERE WAS NOT A SURGICAL DELAY. DOI: (B)(6) 2011. DOR: (B)(6)2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20492555 ↗
• InjurySep 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THERE WAS POSTERIOR WEAR ON INSERT. DOI: (B)(6) 2007. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20127773 ↗
• InjurySep 21, 2023Naturally Worn; Naturally Worn

  PATIENT WAS REVISED WITH POLY WEAR POSTERIOR LATERAL CORNER. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2005; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17790663 ↗
• InjuryMay 24, 2023Fracture; Naturally Worn; Fracture; Naturally Worn

  PATIENT WAS REVISED DUE TO POLY EXCHANGE FOR PAIN AND INSTABILITY. 10MM INSERT HAD WEAR POSTERIOR MEDIAL, A PIECE WAS FRACTURED OFF ROUGHLY L3MM, W8MM AND D3MM. A 15MM INSERT WAS IMPLANTED AND KNEE WAS STABLE IN FULL ROM. DOI: (B)(6) 2005. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 16991453 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PATIENT COMPLAINTS OF PAIN AND A LACK OF MOTION, ASEPTIC LOOSENING OF THE TIBIA WAS SUSPECTED AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 16547934 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN, LACK OF MOTION AND ASEPTIC LOOSENING OF THE TIBIA AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 16453142 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY AND NEEDED TO BE CONVERTED TO A HINGE. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16137332 ↗
• InjuryNov 2, 2022Naturally Worn; Naturally Worn

  CLINICAL ADVERSE EVENT RECEIVED FOR POLY WEAR CAUSING INSTABILITY AND INCREASED PAIN. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT:(B)(6) 2009. DATE OF REVISION: UNK. DATE OF EVENT: (B)(6) 2022. (LEFT KNEE). TREATMENT: REVISION; INSERT WAS REVISED.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 15715913 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BROUGHT IN DUE TO INFECTION. SURGEON IRRIGATED AND WASHED OUT KNEE. KNEE WAS A LITTLE LAX, POLY WAS REMOVED AND ONE THICKNESS LARDER (12.5MM) WAS IMPLANTED. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 15282328 ↗
• InjuryApr 12, 2022Naturally Worn; Naturally Worn

  CLINICAL ADVERSE EVENT RECEIVED FOR TIBIAL INSERT POLY WEAR. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. DATE OF IMPLANT: (B)(6)2001 . DATE OF REVISION: (B)(6)2022. (LEFT KNEE). TREATMENT: REVISION OF INSERT.

  Patient problems: Insufficient Information

  MAUDE report 14084508 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY OPERATIVE NOTES (B)(6) 2009 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. OFFICE NOTES (B)(6) 2021 INDICATE THE PATIENT IS EXPERIENCING PAIN AND SWELLING OF THE RIGHT KNEE IN ADDITION TO THE PREVIOUSLY NOTED AE. NO ADDITIONAL TREATMENT PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Swelling/ Edema

  MAUDE report 12908036 ↗
• InjuryNov 29, 2021Naturally Worn; Naturally Worn

  PATIENT WAS REVISED DUE TO INSTABILITY. A CR RP SIGMA WAS IMPLANTED IN 2007. THE POLY WAS WORN POSTERIORLY/MEDIALLY. SURGEON REMOVED OLD POLY AND PUT IN A THICKER POLY. WENT FROM 10 MM TO 12.5 MM POLY. DOI: 2007, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12887294 ↗
• InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE PAIN. DID A POLY SWAP AND EXPLANTED 3X10 CR/RP INSERT. DOI: (B)(6) 2016. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Pain

  MAUDE report 12569252 ↗
• InjuryAug 31, 2021Naturally Worn; Naturally Worn

  PATIENT WAS REVISED DUE TO PAIN. TIBIAL INSERT HAD POSTERIOR MEDIAL WEAR. REVISED FROM 10MM TO 12.5MM. DOI: (B)(6) 2005 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12392279 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO FALL AT HOME 7 WEEKS POST OPERATIVE. THE KNEE BECAME UNSTABLE. THE FEMORAL AND THE TIBIAL COMPONENTS WERE REVISED TO A TC3/ MBT REVISION TRAY. CEMENT MANUFACTURER IS UNKNOWN. NO LOOSENING NOTED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Fall; No Code Available

  MAUDE report 10788078 ↗
• InjuryOct 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). THIS COMPLAINT IS TO CAPTURE THE REVISION SURGERY REPORTED IN (B)(4). ON (B)(6) 2019 THE PATIENT HAD A REVISION OF THE RIGHT TOTAL KNEE DUE TO RIGHT KNEE INSTABILITY WITH ASEPTIC LOOSENING OF THE FEMORAL COMPONENT AND PAIN. COMPETITOR CEMENT WAS NOTED TO BE USED DURING THE REVISION. DURING THE SURGERY, THERE WAS LYSIS AT THE LATERAL FEMORAL CONDYLE. DOI: (B)(6) 2011; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Osteolysis; Pain

  MAUDE report 10643661 ↗
• InjurySep 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. SURGEON CHOSE TO UPSIZE THE TIBIAL INSERT. NO FURTHER INFORMATION IS AVAILABLE. DOI: 2007 DOR: (B)(6) 2020 LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10501976 ↗
• InjuryFeb 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THEY THOUGHT INFECTION HAD CLEARED BUT IT HAS NOT. SO USING THIS AS TEMPORARY SPACER. NO ADDITIONAL INFORMATION. DOI: UNKNOWN. DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9765501 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. POLY SWAPPED DURING IRRIGATION AND DEBRIDEMENT. NO SURGICAL DELAY REPORTED. NO OTHER INFORMATION AVAILABLE. THIS COMPLAINT CAPTURES PFC SIGMARP CV TB/IN S3 10.0. DOI: UNKNOWN; DOR: (B)(6) 2020; AFFECTED: RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9709950 ↗