P.F.C. SIGMA 96-2033Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295240761), received between Nov 25, 2017 and Mar 19, 2026 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (3 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNSTABLE. THE CR FEMUR WAS REMOVED AND REPLACED WITH A TC3 FEMUR AND A THICKER INSERT. THE CEMENT WAS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 24637542 ↗
• InjuryJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL CASE IN REGARD TO (B)(4). THE PATIENT WILL NEED A BILATERAL TOTAL KNEE REPLACEMENTS ON THE LEFT SIDE AT A LATER STAGE. SHE CURRENTLY HAS INSITU A 15MM THICK POLY AND THE SURGEON NEEDS TO HAVE 17.5 AND A 20MM THICK INSERT AVAILABLE AND HAS ASKED FOR A CUSTOM IMPLANT TO MAKE THE 20MM THICKNESS AS IT LONGER EXISTS.

  Patient problems: Joint Laxity

  MAUDE report 21091586 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD BILATERAL TOTAL KNEE REPLACEMENTS AND HAS PRESENTED WITH INSTABILITY AND LAXITY AND REQUIRES A REVISION ON THE RIGHT SIDE AND WILL NEED A REVISION ON THE LEFT SIDE AT A LATER STAGE. INSITU CURRENTLY IS A 15MM THICK POLY AND THE SURGEON NEEDS TO HAVE 17.5 AND A 20MM THICK INSERT AVAILABLE AND HAS ASKED FOR A CUSTOM IMPLANT TO MAKE THE 20MM THICKNESS AS IT LONGER EXISTS.

  Patient problems: Joint Laxity

  MAUDE report 21085415 ↗
• InjuryNov 18, 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 INSTABILITY. DATE OF INDEX SURGERY IS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 20710326 ↗
• InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON REMOVED A SIZE 3 X 10 CURVED POLY AND IMPLANTED A SIZE 3 X 15 POLY. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18685682 ↗
• InjuryOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. IS THE REVISION DATE PLANNED? WHEN WOULD BE THE REVISION DATE? PLANNED REVISION DATE (B)(6) 2023. B. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? NO. C. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO.

  Patient problems: Joint Laxity

  MAUDE report 17887299 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THERE WAS NO LOOSENING AND NO SURGICAL DELAY. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15249545 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY AND INCREASED PAIN. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2014, DATE OF EVENT: (B)(6) 2022, (RIGHT KNEE). TREATMENT: REVISION; INSERT WAS REMOVED.

  Patient problems: Joint Laxity; Osteolysis; Pain; Physical Asymmetry; Swelling/ Edema

  MAUDE report 15163408 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI- (B)(6) 2003; DOR- (B)(6) 2022; AFFECTED SIDE- LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14205664 ↗
• InjuryMar 31, 2022Naturally Worn; Naturally Worn

  CLINICAL ADVERSE EVENT RECEIVED FOR POLY FAILURE, TIBIAL : WEAR. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2006. DATE OF EVENT (ONSET): (B)(6) 2021. (LEFT KNEE). TREATMENT: REVISION ON 02/09/2022, WITH REVISION OF TIBIAL INSERT.

  Patient problems: Insufficient Information; Pain; Synovitis

  MAUDE report 13965737 ↗
• InjurySep 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ALSO EXPERIENCING DIFFICULTY WALKING DUE TO THE RIGHT KNEE PRIOR TO THE RIGHT KNEE REVISION ON (B)(6) 2016.

  Patient problems: Ambulation or Postural Difficulties; Edema; Injury; Limited Mobility Of The Implanted Joint; Muscular Rigidity; No Code Available; Pain

  MAUDE report 10592968 ↗
• InjuryMar 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT KNEE REVISION; SURGEON: (B)(6), PRIMARY IMPLANT DATE: (B)(6) 2008. REASON FOR REVISION: PATIENT FELL 12 MONTHS AGO, INSTABILITY NOTED SINCE THIS INCIDENT. THIS IS THE PATIENT'S FIRST REVISION. GOOD OUTCOME POST SURGERY; NO ADVERSE EFFECT ON PATIENT. FEMALE PATIENT (B)(6), DOB: (B)(6) YEARS OLD, (B)(6) KGS.

  Patient problems: Fall; No Code Available

  MAUDE report 9874359 ↗
• MalfunctionMay 1, 2019Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE OPENED STERILE PACKING WAS DISCOVERED A HAIR WRAPPED AROUND KEEL OF INSERT. SURGEON WAS NOT UPSET AND HAS FORGOTTEN ABOUT IT NOR WAS HOSPITAL UPSET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8568686 ↗
• InjuryJan 2, 2019Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS SECONDARY INSTABILITY.

  Patient problems: No Code Available

  MAUDE report 8211156 ↗
• InjuryMay 7, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAINFUL KNEE DUE TO INSTABILITY. DOI: (B)(6) 2015; DOR: (B)(6) 2018; UNKNOWN OPERATIVE SIDE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7490475 ↗
• InjuryNov 25, 2017Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  RIGHT KNEE PAIN DUE TO POLY WEAR OF TIBIAL INSERT.

  Patient problems: Pain

  MAUDE report 7058090 ↗