P.F.C. SIGMA 96-2134Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295241270), received between Aug 4, 2017 and Aug 8, 2024 — classified as 19 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD POSSIBLE INFECTION, SURGEON PERFORMED I AND WITH A POLY SWAP. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2011. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19938105 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: PAIN.

  Patient problems: Pain

  MAUDE report 18980466 ↗
• InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. PREVIOUS SURGERY DATE AND LOCATION ARE UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16272362 ↗
• InjuryJul 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TIBIAL COMPONENT HAD COLLAPSED INTO VARUS AND INCREASED AMOUNT OF POSTERIOR SLOPE. PATIENT WAS UNSTABLE AND IN PAIN. DOI: NOV 17, 2016. DOR: (B)(6) 2022. AFFECTED SIDE: UNK KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 14936410 ↗
• InjuryJul 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED AS THE TIBIAL COMPONENT HAD COLLAPSED INTO VARUS AND INCREASED AMOUNT OF POSTERIOR SLOPE. PATIENT WAS UNSTABLE AND IN PAIN. NO OTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2016. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 14932771 ↗
• MalfunctionApr 7, 2022Defective Device; Defective Device

  CONE ON THE RP INSERT WAS TOO WIDE TO FIT INTO MBT REVISION TRAY. CONES WERE MEASURABLY DIFFERENT, CLOSE TO 1MM THICKER. ANOTHER IMPLANT WAS OPENED AND USED TO COMPLETE THE SURGERY. SURGICAL DELAY OF 20 MINUTES OCCURRED. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: UNKNOWN KNEE AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14042179 ↗
• InjuryNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI : UNKNOWN, DOR : (B)(6) 2021, RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12892647 ↗
• InjuryDec 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS VARUS/VALGUS INSTABILITY, PAIN AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. NOTHING FURTHER INFORMATION. NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11081375 ↗
• InjuryDec 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY OF THE KNEE. PUT IN A THICKER INSERT. NO FURTHER INFORMATION IS AVAILABLE. NO SURGICAL DELAY. DOI: (B)(6) 2016, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11050619 ↗
• InjurySep 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS ARTHROFIBROSIS. AN EXTENSIVE SYNOVECTOMY AND A POLY EXCHANGE WERE DONE. DOI: (B)(6) 2018, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 10524449 ↗
• InjuryMar 26, 2020Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. IT WAS ALSO REPORTED THAT THE SURGEON DECIDED TO REMOVE THE FEMORAL COMPONENT AND PUT A NEW KNEE IN. THE POLY INSERT SHOWED REMARKABLY LITTLE WEAR. THE FEMUR WAS NOT LOOSE AND THE PATELLA SHOWED SOME WEAR SO HE REPLACED IT. DOI: APPROX. 10 YEARS AGO; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9884050 ↗
• InjuryOct 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. THE INFORMATION BELOW WAS ALL THAT I WAS ABLE TO DOCUMENT DURING SURGERY. DOI: UNKNOWN, DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: Joint Disorder; No Code Available

  MAUDE report 9225899 ↗
• InjuryAug 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. POLY SWAP WAS DONE. DOI: (B)(6) 2019. DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8865746 ↗
• InjuryMar 20, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REMOVAL OF SIGMA PS FEMUR AND PS LINER DUE TO GROSS INSTABILITY. CONVERSION TO NOILES HINGE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8437396 ↗
• InjuryFeb 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTED RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8361636 ↗
• InjuryNov 21, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISED DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 8095842 ↗
• InjuryNov 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT KNEE REVISION DUE TO PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8088829 ↗
• InjuryJun 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. REVISED TO A SPACER. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7581891 ↗
• InjuryApr 2, 2018Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED.

  Patient problems: Not Applicable

  MAUDE report 7389217 ↗
• InjuryAug 4, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAINFUL KNEE.

  Patient problems: Pain

  MAUDE report 6766398 ↗