P.F.C. SIGMA 96-2142Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 10603295241324), received between Aug 25, 2017 and Apr 24, 2026 — classified as 70 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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 70 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SEPTIC A LOOSENING. IT WAS STATED THAT FEMUR/TIBIA WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS UNKNOWN. DOI: (B)(6) 2017. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 24981543 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION, WASHOUT AND POLY SWAP. DOI: (B)(6) 2015. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24415329 ↗
• 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 24387709 ↗
• InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTION, POLY SWAPPED. AFFECTED SIDE: UNKNOWN SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 22814800 ↗
• InjuryAug 1, 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 Q2 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: THE SIGMA FEMORAL COMPONENT, FEMORAL SLEEVE, FEMORAL STEM, INSERT, TIBIAL TRAY, TIBIAL SLEEVE, AND TIBIAL STEM WERE REVISED FOR INFECTION. THE INSERT SHOWED MODERATE YELLOWING.

  Patient problems: Unspecified Infection

  MAUDE report 22686131 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A SIGMA KNEE DONE IN 2015. THE PATIENT LOST MOTION, AND SURGEON WENT IN AND REMOVED A BUNCH OF SCAR TISSUE AND REPLACED THE INSERT AND PATELLA. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 21315315 ↗
• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD KNEE REVISION YEARS AGO AND WAS HAVING SOME KNEE PAIN. SURGEON IDENTIFIED A NATIVE LOOSE BODY ON X-RAY AND DECIDED TO REMOVE THE LOOSE BODY AND REPLACE THE POLY. AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Pain

  MAUDE report 21303588 ↗
• InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THEY WASHED OUT KNEE AND CHANGED INSERTS. ORIGINAL SURGERY WAS IN 2012. NO FURTHER INFORMATION IS AVAILABLE. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE

  Patient problems: Unspecified Infection

  MAUDE report 19477966 ↗
• InjuryMay 2, 2024Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION WAS RECEIVED: A. PLEASE CLARIFY IF THE TIBIAL TRAY AND PATELLA WAS NOT REVISED.NO BECAUSE TIBIA AND PATELLA OK B. PLEASE CLARIFY IF THERE WAS AN ISSUE WITH THE PATIENT'S BONE QUALITY AS NOTED WITHIN (B)(6). WAS IT DEVICE/PROCEDURE RELATED FOR DUE TO THE PATIENT? NO.

  Patient problems: Joint Laxity

  MAUDE report 19234618 ↗
• InjuryApr 11, 2024Fracture; Naturally Worn; Unintended Movement; Fracture; Naturally Worn; Unintended Movement

  IT WAS REPORTED THAT THE CAM OF THE POLY HAD BROKEN OFF OR WORN DOWN. POLY WAS SPUN AROUND BACKWARDS. THERE WAS NO LOOSENING.

  Patient problems: Insufficient Information

  MAUDE report 19090973 ↗
• InjuryFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SIGN OF INFECTION, SO THEY DID I & D AND SWAPPED POLY S. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18788267 ↗
• InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION FOR RIGHT KNEE PAIN DUE TO TIBIAL IMPACTION. NO TIBIAL LOOSENING. PATELLA LATERAL TILT WITHOUT LOOSENING. DOI: (B)(6) 2008. DOE: (B)(6) 2024.

  Patient problems: Joint Laxity; Pain

  MAUDE report 18703213 ↗
• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 18651218 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL KNEE. DOI: (B)(6) 2012. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 18443155 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. NEW POLY IMPLANTED. NO FURTHER INFORMATION AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 18363491 ↗
• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS AN INFECTION SO DOCTORS DECIDED TO DO A POLY EXCHANGE. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN, DOR- (B)(6) 2023, AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18318409 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED AND UPSIZED FEMORAL IMPLANT DUE TO FLEXION INSTABILITY. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2023, DOR- (B)(6) 2023, AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18305691 ↗
• InjuryOct 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO A DISLOCATED KNEE. DOI: UNKNOWN. DOR: 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 18002765 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A POLY SWAP AND DEBRIDEMENT FOR STIFFNESS. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 17583601 ↗
• InjuryJul 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SEVERE PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2010; DATE OF REVISION: (B)(6) 2013; DATE OF EVENT: (B)(6) 2011; (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, TIBIAL BASE, AND INSERT WERE REVISED.

  Patient problems: Pain

  MAUDE report 17412569 ↗
• InjuryJul 12, 2023Adverse 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 A KNOWN INFECTION. I&D WITH POLY EXCHANGE WAS PERFORMED. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17310377 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION OF RIGHT KNEE. ALL IMPLANTS WERE REMOVED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16862242 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. SURGEON SWAPPED INSERT. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16419605 ↗
• InjuryDec 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 15958454 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND INFECTION ON RIGHT KNEE. DOR: ON (B)(6) 2022. AFFECTED SIDE: RIGHT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 15927478 ↗