P.F.C. SIGMA 96-2131Recalls & reported problems

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 10603295241249), received between Sep 29, 2017 and Nov 11, 2025 — classified as 91 injuries.

The most frequently reported specific device problem is “Naturally Worn” (13 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 91 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL LEFT KNEE. REMOVED A CORTICAL SCREW FROM THE SIDE PLATE THAT WAS 1CM TOO LONG. SURGEON OPTED TO CHANGE THE POLY. DOI: (B)(6) 2005. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 23522424 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. (B)(6) 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 TIBIAL LOOSENING, FEMORAL OSTEOLYSIS, INSTABILITY, AND PAIN. THE NON-ARTICULAR SURFACE OF THE TIBIAL TRAY NO CEMENT REMAINING.

  Patient problems: Joint Laxity; Osteolysis; Pain

  MAUDE report 23458222 ↗
• InjuryJan 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO THE INSERT HAD A POSTERIOR MEDIAL CRACK IN IT AND PATELLA COMPONENT WAS LOOSE. THE LOOSENING INTERFACE OF THE PATELLA COMPONENT IS CEMENT/IMPLANT. BOTH WERE EXCHANGED FOR NEW IMPLANTS. THERE WAS NO SURGICAL DELAY AND ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2008. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21257488 ↗
• InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO HAVING SLIGHT INSTABILITY. THE PATELLA AND POLY EXCHANGE WAS PERFORMED. THERE WERE NO ADVERSE CONSEQUENCES DUE TO SURGERY AND THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE

  Patient problems: Joint Laxity

  MAUDE report 21251695 ↗
• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q4 OF 2024. (B)(6) 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 LOOSE TIBIA (UNKNOWN INTERFACE), OSTEOLYSIS BEHIND FEMUR, PAIN, AND VARUS DEFORMITY.

  Patient problems: Osteolysis; Pain

  MAUDE report 21027997 ↗
• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. INFECTED ONE WASHOUT WITH NEW POLY. DOI: UNKNOWN, DOR: UNKNOWN, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20726678 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO STIFFNESS AND PAIN. NO LOOSE IMPLANT INTERFACES. DOI: (B)(6) 2015. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 20521579 ↗
• InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO UNSTABLE KNEE. IT WAS CHANGED TO A LARGER POLY INSERT. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2012, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 20422910 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT WAS REVISED DUE TO ACUTE INFECTION-NO IMPLANT LOOSENING, NO PRODUCT COMPLAINT. ALL PIECES OF POLY RETRIEVED FROM PATIENT. THERE WAS NO SURGICAL DELAY. NO COMPLAINTS. NO OTHER INFORMATION KNOWN. DOI: (B)(6) 2010, DOR: (B)(6) 2024, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 20397977 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT NO DELAYS IN SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 20031938 ↗
• InjuryAug 6, 2024Naturally Worn; Naturally Worn

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: REVISION DUE TO LOOSENING, POLY WEAR, AND PAIN. AT REVISION THE NON-ARTICULAR SURFACE OF THE CEMENTED CC FEMORAL COMPONENT SHOWS MODERATE CEMENT REMAINING AND THE NON-ARTICULAR SURFACE OF THE CEMENTED TIBIAL TRAY SHOWS SPARSE CEMENT REMAINING. CEMENT MFG IS UNKNOWN. THE ARTICULAR SURFACE OF THE MOBILE-BEARING POLYETHYLENE TIBIAL INSERT SHOWS IMPINGEMENT OF THE INTERCONDYLAR EMINENCE.

  Patient problems: Pain

  MAUDE report 19923799 ↗
• InjuryApr 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO POLY WEAR. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Insufficient Information

  MAUDE report 19153052 ↗
• InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S KNEE WAS REVISED DUE TO INSTABILITY. HER PRIMARY 10MM SIGMA RP PS INSERT WAS REMOVED AND REPLACED BY A THICKER 15MM SIGMA RP PS INSERT, WHICH TIGHTENED BOTH HER FLEXION AND EXTENSION GAPS. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2012 DOR:(B)(6) 2024 AFFECTED SIDE: RIGHT KNEE

  Patient problems: Joint Laxity

  MAUDE report 19127944 ↗
• InjuryFeb 27, 2024Naturally Worn; Naturally Worn

  PATIENT WAS REVISED TO TOTAL KNEE ARTHROPLASTY. THE PATELLA TRACKING WAS OFF DUE TO AN OSTEOPHYTE. RP PS INSERT WAS REMOVED DUE TO MINOR POLYETHYLENE WEAR. DOI: (B)(6), 2005. DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Unspecified Musculoskeletal problem

  MAUDE report 18787144 ↗
• InjuryFeb 20, 2024Naturally Worn; Naturally Worn

  PATIENT WAS REVISED DUE TO WEAR ON INSERT AND LOOSENING OF TIBIAL IMPLANT FROM CEMENT. FEMUR WAS ALSO MISPOSITIONED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE : LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 18739515 ↗
• InjuryJan 23, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THIS PATIENT CAME INTO THE ER AT TROY BEAUMONT FOR KNEE AND ANKLE PAIN. EXAMINATION INDICATED AN INFECTION IN LEFT TKA AND AS WELL IN HER ANKLE JOINT. SURGEON WAS ASSIGNED THE CONSULT AND DID IRRIGATION AND DEBRIDEMENT (I&D) OF HER KNEE WITH A POLY EXCHANGE. THE ORIGINAL DATE OF SURGERY, THE PLACE OF SURGERY, AND THE PHYSICIAN WHO DID THE SURGERY ARE UNKNOWN. THE FEMORAL , TIBIAL, AND PATELLA COMPONENTS WERE LEFT IN SITU. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6),2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain; Unspecified Infection

  MAUDE report 18562311 ↗
• InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME INTO THE EMERGENCY ROOM FOR KNEE AND ANKLE PAIN. EXAMINATION INDICATED SHE HAS AN INFECTION IN HER LEFT TKA AND AS WELL IN HER ANKLE JOINT. THE SURGEON ASSIGNED THE CONSULT AND DID AN IRRIGATION AND DEBRIDEMENT (I&D) OF HER KNEE WITH A POLY EXCHANGE. THE ORIGINAL DATE OF SURGERY, THE PLACE OF SURGERY, AND THE PHYSICIAN WHO DID THE SURGERY ARE UNKNOWN. THE FEMORAL, TIBIAL, AND PATELLA COMPONENTS WERE LEFT IN SITU. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 18541797 ↗
• InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME FOR KNEE AND ANKLE PAIN, EXAMINATION INDICATED INFECTION IN LEFT TKA AND AS WELL IN ANKLE JOINT. THE SURGEON DID AN IRRIGATION AND DEBRIDEMENT (I&D) OF KNEE WITH A POLY EXCHANGE. THE FEMORAL , TIBIAL, AND PATELLA COMPONENTS WERE LEFT IN SITU. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 18541795 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 9 DAYS POST-OP FROM LEFT TKA, THE KNEE WAS RED AND SWOLLEN. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Swelling/ Edema

  MAUDE report 18256324 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED KNEE. THERE WAS LOOSENING OF THE TIBIA AT CEMENT TO IMPLANT INTERFACE. THE CEMENT MANUFACTURER WAS UNKNOWN. NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17487336 ↗
• InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION ON (B)(6) 2023, DUE TO POSSIBLE INFECTION. DATE OF ORIGINAL IMPLANT WAS (B)(6) 2011. THIS REPORT IS FOR A PFC SIGMARP STB TB IN 3 10.0. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 17317650 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INSTABILITY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17170700 ↗
• InjuryMay 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. SURGEON WENT UP A SIZE IN POLY THICKNESS. NO INSTRUMENTS WERE BROKEN DURING SURGERY. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17002982 ↗
• InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN WITH A FAILED TKA. SURGEON, HOSPITAL AND DATE IT WAS IMPLANTED WAS NOT AVAILABLE. THE SURGEON REMOVED A SIGMA PS CONSTRUCT AND REIMPLANTED AN ATTUNE REVISION. THE PATELLA COMPONENT WAS LEFT. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16822566 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH A SIGMA TOTAL KNEE, BUT SURGEON WAS UNSURE OF WHO THE ORIGINAL IMPLANTING SURGEON WAS. HE ALSO WAS UNSURE OF WHEN THE PATIENT HAD THEIR ORIGINAL SURGERY DONE AND WHERE IT WAS DONE. THE PATIENT'S KNEE WAS GROSSLY UNSTABLE AND SURGEON FELT THEY WOULD BENEFIT FROM A FULL TEAR OUT AND PLACEMENT OF AN ATTUNE REVISION. THE KNEE WAS FULLY REVISED TO A FB ATTUNE REVISION AND STABILITY WAS ACHIEVED THROUGH FULL RANGE OF MOTION. CLOSING PROCESS BEGAN. DOI- UNKNOWN. DOR- (B)(6) 2023. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16745147 ↗