P.F.C. SIGMA 96-2141Recalls & reported problems

Summary

The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 10603295241317), received between Jun 26, 2017 and Apr 9, 2026 — classified as 100 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (11 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 102 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI-UNKNOWN. DOR- (B)(6) 2026. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Pain

  MAUDE report 24825784 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS REVISED WITH POLY SWAP FOR LATE INFECTION. PATELLA WAS REMOVED AS WELL.

  Patient problems: Unspecified Infection

  MAUDE report 24301750 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO KNEE PATELLA LOOSENING AT BONE TO CEMENT INTERFACE. THE SURGEON WANTED TO INCREASE THE THICKNESS OF THE POLYETHYLENE SPACER TO INCREASE STABILITY. THE PATELLA WAS REMOVED DUE TO MALTRACKING. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24068390 ↗
• InjuryDec 30, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK FOR Q4 OF 2025. DARTMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION FOR PAIN. THE ARTICULAR SURFACE OF THE MOBILE-BEARING POLYETHYLENE TIBIAL INSERT SHOWS MINOR YELLOWING.

  Patient problems: Pain

  MAUDE report 23923311 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23719581 ↗
• InjuryNov 4, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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 ARTHROFIBROSIS. TIBIAL INSERT SHOWED MINOR YELLOWING.

  Patient problems: Adhesion(s)

  MAUDE report 23464598 ↗
• 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 22301461 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INCREASED PAIN, REDNESS, AND MILD ERYTHEMA. IV ANTIBIOTICS WAS STARTED FOR TREATMENT OF POSSIBLE CELLULITIS. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Cellulitis; Erythema; Pain

  MAUDE report 21996192 ↗
• InjuryJan 17, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT WHEN REMOVING THE TRAY, THERE WAS NO CEMENT ON THE IMPLANT. THE INSERT HAD SIGNS OF WEAR ON THE INSERT. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21182189 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT TOTAL KNEE JOINT EXPLANT DUE TO KNEE JOINT INFECTION. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2017. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20577332 ↗
• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 20333780 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED KNEE. NO LOOSENING IS THERE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20135934 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DUE TO INFECTION IN PATIENT, REPLACEMENT OF INSERT AND WASHOUT WAS REQUIRED. INSERT THAT WAS REMOVED WAS SIGMA TIBIAL INSERT ROTATING PLATFORM, STABILIZED 4/10MM. INSERT NOT KEPT DUE TO INFECTION STATUS.

  Patient problems: Unspecified Infection

  MAUDE report 19960094 ↗
• InjuryMar 27, 2024Adverse 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 INFECTION. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18988452 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTED TOTAL KNEE. ORIGINAL DOS WAS 2009. EXCHANGED INSERT AFTER WASH OUT. DOI: 2009. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17859799 ↗
• InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DATE OF IMPLANTATION UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17806795 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, PATIENT'S RIGHT KNEE WAS REVISED AND UNDERWENT AN I&D, DUE TO A SUSPECTED INFECTION. THIS REPORT IS FOR A PFC SIGMARP STB TB IN 4 10.0. THIS IS REPORT 1 OF 1 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 17301913 ↗
• InjuryJun 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014 - (B)(6) 2014, MEDICAL RECORDS REPORTED THAT THE PATIENT UNDERGOES A STEROID INJECTION FOR RIGHT KNEE PAIN AND CREPITATION DOI: (B)(6) 2012; DOE: UNKNOWN; RIGHT KNEE.

  Patient problems: Pain; Unspecified Musculoskeletal problem

  MAUDE report 17086001 ↗
• InjuryJun 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020: PATIENT COMPLAINS OF RIGHT KNEE PAIN. AN ASPIRATION IS DONE TO RULE OUT INFECTION. DOI: (B)(6)2012; DOE: (B)(6)2020; RIGHT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17085717 ↗
• InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INCREASING PAIN & DEFORMITY OVER TIME. TIBIAL REVISION WAS PERFORMED. THERE WAS INDICATED LOOSENING OF TIBIAL TRAY AT CEMENT TO IMPLANT INTERFACE. THERE IS NO SURGICAL DELAY. DOI: (B)(6) 2009. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain; Physical Asymmetry

  MAUDE report 17010107 ↗
• InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH POLY EXCHANGE DUE TO INFECTION, I&D. SURGEON TOOK OUT A 4X10 SIGMA RP PS AND WENT UP A SIZE TOE 4X12.5. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16808405 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON STATED THE PATIENT GOT SCRATCHED BY A CAT AND THE INFECTION GOT INTO THE PATIENTS BLOOD STREAM. THEY WASHED OUT AND SWAPPED THE POLY. NO OTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2013. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16378539 ↗
• InjuryFeb 1, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT PRESENTS IN SURGEON OFFICE UNABLE TO WALK ON HIS RTKA. IMPLANTS APPEAR TO BE STABLE AND WELL FIXED AND STABILITY SEEMS SATISFACTORY, HOWEVER PATIENT CAN GROSSLY HYPEREXTEND. PATIENT STATES KNEE WAS PUT IN IN 2010. NO RECORDS COULD BE FOUND UNDER HIS NAME. ONCE THE KNEE IS EXPOSED, PS POST IS FOUND TO BE BROKEN. SIZE IS IDENTIFIED ON THE IMPLANT AND A THICKER INSERT IS PLACED AND STABILITY IS QUITE GOOD. PATELLA IS NATIVE BUT DOES NOT TRACK WELL. A LATERAL RELEASE IS PERFORMED AND A PATELLAR COMPONENT IS PLACED. NO MALALIGNMENT WAS NOTED, TIBIAL AND FEMORAL COMPONENTS ARE APPROPRIATELY SIZED AND WELL FIXED, AND NO POLY WEAR IS FOUND. NO PATIENT HARM OCCURRED. SURGEON BELIEVES THAT PATIENT MUST HAVE DEVELOPED SOME LAXITY OVER TIME AND THAT LAXITY LEAD TO INCREASED STRESS ON THE POST, CAUSING BREAKAGE. DOI: (B)(6) 2010. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Loss of Range of Motion

  MAUDE report 16277101 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO A PAINFUL KNEE. PREVIOUS SURGERY WAS PERFORMED APPROXIMATELY 17 YEARS AGO. NO SURGICAL DELAY WAS REPORTED. DOI: 17 YEARS AGO. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15924512 ↗
• InjuryAug 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A KNEE SURGERY WAS DONE 1 YEAR AGO, (B)(6) 2021. SENT FOR MEDICAL RECORDS, PHYSICAL THERAPY 35 TIMES AND THEN 22 MORE SESSIONS (57 TOTAL). REVISION KNEE SURGERY REQUIRED, LOOSE LIGAMENTS, DEPUY CEMENT. SHE CALLED THE REPORTER AS THE REPORTER WAS LISTED ON A RECALL SHE FOUND ONLINE. THE REPORTER HAS CALLED HER A FEW TIMES AND SHE HAS CALLED THE REPORTER A FEW TIMES. THEY JUST CONNECTED. DOI: (B)(6) 2021; AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 15300049 ↗