P.F.C. SIGMA 96-2151Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10603295241386), received between Oct 19, 2017 and Aug 5, 2025 — classified as 60 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 60 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT POSTOPERATIVELY, THE SIGMA TIBIAL INSERT WAS REVISED FOR POLY WEAR. THE INSERT SHOWED MINOR YELLOWING.

  Patient problems: Insufficient Information

  MAUDE report 22715681 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTION IN LEFT KNEE. THE SURGEON DECIDED TO DO A POLY SWAP WITH ANTIBIOTIC BEADS AFTER A THOROUGH WASH OUT. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22553766 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WASH OUT AND POLY SWAP PERFORMED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22157631 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION IN THE KNEE, WHICH LED TO A WASHOUT WITH POLY EXCHANGE. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20747639 ↗
• InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOTH OF THESE HAPPENED WITHIN THE SAME CASE. 1. REMOVAL OF SIGMA RP STAB POLY FOR A DAIR INFECTION WASHOUT OUT + POLY SWAP CASE. 2. PRIMARY ARTHROPLASTY SURGEON HAD USED A DEPUY SYNTHES TIBIAL IMPLANT (SIGMA PFC RP STAB SIZE 5 10MM) WITH A DIFFERENT COMAPANY'S CRUCIATE RETAINING (CR) FEMORAL COMPONENT. PATIENT CAME INTO THEATRE FOR A DAIR INFECTION WASHOUT + POLY SWAP AND [SURGEON] SWAPPED THE STAB POLY OUT FOR A CR VERSION OF THE POLY. IT IS OFF LABEL TO USE OUR TIBIAL IMPLANTS WITH ANOTHER COMPANY'S FEMORAL IMPLANTS, BUT SURGEON DID NOT WANT TO DO A FULL REVISION SURGERY WHILST THE PATIENT WAS INFECTED. SURGEON UNDERSTOOD THAT IT WAS CONTRAINDICATED HOWEVER SAID IT WAS THE BEST THING FOR THE PATIENT ON THE DAY.

  Patient problems: Unspecified Infection

  MAUDE report 19126776 ↗
• InjuryFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POLY SWAPPED WAS PERFORMED IN AN I&D PROCEDURE. POLY THICKNESS WAS INCREASED BY ONE SIZE. ANTIBIOTICS WERE ALSO USED. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2012. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18788170 ↗
• InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. DONE ABOUT 10 YEARS AGO ACCORDING TO PATIENT. NO RECORD. THE PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D) WITH POLY EXCHANGE FOR RESPECTED INFECTION. NO WAY TO CONFIRM INFECTION. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: JAN 3, 2024. AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 18570448 ↗
• InjuryJan 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: JANUARY 9, 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 18526058 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD POLY EXCHANGE DUE TO PAIN. NEW POLY IMPLANTED. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. NO FURTHER INFORMATION AVAILABLE. DOI- UNKNOWN DOR- (B)(6) 2023 AFFECTED SIDE- LEFT KNEE.

  Patient problems: Pain

  MAUDE report 18356237 ↗
• InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. POLY WAS REMOVED AND NEW ONE WAS PUT IN. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN; DOR- (B)(6) 2023; AFFECTED SIDE- UNKNOWN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17843898 ↗
• InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SEPTIC KNEE WASH OUT WITH POLY SPACER EXCHANGE. ACTIVITY LEVEL WAS YES. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17019070 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL RIGHT KNEE. PREVIOUS SURGERY DATE AND LOCATION IS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16914821 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO LOOSENING OF THE TIBIAL COMPONENT AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. DOI- UNKNOWN. DOR- (B)(6) 2022. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16253761 ↗
• InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION WITH SPACER EXCHANGE. I&D OF KNEE WAS COMPLETED. THERE WAS NO LOOSENING AND NO SURGICAL DELAY. DOI: ON (B)(6) 2020. DOR: ON (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15937112 ↗
• InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAINFUL KNEE. INCREASED INSERT THICKNESS. DOI: (B)(6) 2019; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 15348854 ↗
• InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO INFECTED TOTAL KNEE. POLY LINER EXCHANGED. THERE WAS NO LOOSENING AND NO SURGICAL DELAY. DOI: (B)(6),2014. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15265579 ↗
• InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFC KNEE REVISION. PATIENT HAD SURGERY DONE APPROX 10-15 YEARS AGO, PATELLA WAS NEVER RESURFACED, EXPERIENCED SOME ANTERIOR KNEE PAIN OVER TIME. SURGEON ORGANISED REVISION SURGERY TO RESURFACE THE PATELLA AND DECIDED TO SWAP THE POLY OVER WHILE HE WAS IN THERE AS A FRESHEN UP. NO DISLOCATION OR SIGNIFICANT WEAR TO POLY, EXACT SAME SIZE WAS TAKEN OUT AND REPLACED. SIGMA PFC SIZE 5 10 MM PS RP INSERT. DOI: UNKNOWN, DOR: (B)(6) 2022, UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 15051705 ↗
• InjuryMay 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND EFFUSION. THE CEMENT MANUFACTURER WAS UNKNOWN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2010; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 14434057 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE PAIN, THEY DID CLEAN OUT AND A POLY SWAP. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE AFFECTED.

  Patient problems: Pain

  MAUDE report 14073558 ↗
• InjuryJan 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC WAS CREATED FOLLOWING AND ADDITIONAL INFORMATION RECEIVED ON THE MOTHER (B)(4) FOUND IN AEI NOTE (B)(4). ON (B)(6) 2019: R TKA IS PERFORMED. SPECIFIC PART/LOT NOT IDENTIFIED. ON (B)(6) 2019: PATIENT HAS ONGOING STIFFNESS AND PAIN. ON (B)(6) 2019 RIGHT KNEE UNDERGOES MANIPULATION DUE TO LACK OF MOTION. DOI: (B)(6) 2019, DOE: (B)(6) 2019, RIGHT KNEE.

  Patient problems: Adhesion(s); Loss of Range of Motion; Muscular Rigidity; Pain

  MAUDE report 13153995 ↗
• InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IRRIGATION AND DEBRIDEMENT WERE PERFORMED DUE TO INFECTION. THE POLYETHYLENE WAS EXCHANGED. DOI: UNKNOWN, DOR: (B)(6) 2021, UNKNOWN AFFECTED SIDE.

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

  MAUDE report 12497210 ↗
• InjuryJun 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS ANTERIOR KNEE PAIN. PATELLA WAS RESURFACED AND SWAPPED POLY TODAY. IT WAS REPORTED THAT THE PATIENT HAD A PREVIOUS TKA PERFORMED AT (B)(6) PRIOR TO 2018. DOI: (B)(6) 2015, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12076862 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION FOR KNEE LAXITY.

  Patient problems: Joint Laxity

  MAUDE report 11869843 ↗
• InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  QUESTIONS: A, WAS INSTABILITY DUE TO A FALL? B. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? C. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? D. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? E. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? ANSWER: YES. THE INSTABILITY WAS DUE TO THE FALL AS STATED. NO IS THE ANSWER FOR QUESTIONS B,C,D,E.

  Patient problems: Fall; Joint Laxity

  MAUDE report 11726671 ↗
• InjuryApr 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS STIFFNESS. NEW INSERT IMPLANTED. NO FURTHER INFORMATION AVAILABLE. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 11640720 ↗