P.F.C. SIGMA 96-0113Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295232698), received between Nov 2, 2017 and May 9, 2025 — classified as 12 injuries.

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 21996047 ↗
• 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 17086073 ↗
• 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 17085607 ↗
• InjuryAug 24, 2022Fracture; Adverse Event Without Identified Device or Use Problem; Migration; Fracture; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT THE CONSUMER HAD A REPLACEMENT FOR LEFT AND RIGHT KNEE. CONSUMER REPORTS PAIN. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain; Swelling/ Edema; Unspecified Musculoskeletal problem; Unspecified Tissue Injury

  MAUDE report 15282918 ↗
• InjuryMay 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THE CEMENT MANUFACTURER WAS NOT INDICATED. NO REPORTED LOOSENING. UNKNOWN IF ANY SURGICAL DELAY. DOI: (B)(6) 2013; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 14407664 ↗
• InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT KNEE TO ADDRESS INFECTION. DATE OF IMPLANTATION: (B)(6) 2017, DATE OF REVISION: (B)(6) 2022, (RIGHT KNEE). TREATMENT: REVISION OF FEMUR, TIBIAL TRAY, INSERT, AND PATELLA.

  Patient problems: Unspecified Infection

  MAUDE report 13653327 ↗
• InjuryOct 21, 2020Naturally Worn; Naturally Worn

  PATIENT WAS REVISED DUE TO LOOSENING OF THE PATELLA AT THE BONE TO CEMENT INTERFACE. CEMENT USED WAS UNKNOWN. ALL 3 PEGS HAD WORN OFF THE BACKSIDE OF THE PATELLA CAUSING PAIN. NO FURTHER INFORMATION AVAILABLE. DOI: UNKNOWN DOR: (B)(6) 2020 LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10711624 ↗
• InjuryJun 5, 2020Loss of or Failure to Bond; Unintended Movement; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loss of or Failure to Bond; Unintended Movement; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL KNEE TO ADDRESS IMPLANT MIGRATION WITH IMPLANT LOOSENING OF THE PATELLA COMPONENT. DATE OF IMPLANTATION: (B)(6) 2018. DATE OF REVISION: (B)(6) 2020. (RIGHT KNEE). TREATMENT: PATELLA AND TIBIAL INSERT COMPONENTS WERE REVISED.

  Patient problems: No Code Available

  MAUDE report 10125528 ↗
• InjuryMar 25, 2019Naturally Worn; Naturally Worn

  PATIENT WAS REVISED DUE TO LOT OF WEAR ON THE PATELLA AS WELL AS A LITTLE POLY WEAR AND INSTABILITY. SO THE SURGEON REMOVED PATELLA AND POLY AND PUT IN A THICKER POLY TO HELP WITH STABILITY AND RE-PREPPED THE PATELLA. DOI: UNKNOWN. DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 8447494 ↗
• InjuryJan 9, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE FEMORAL AND PATELLAR COMPONENTS AT THE BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACES.

  Patient problems: No Code Available; Pain

  MAUDE report 8230994 ↗
• InjuryMar 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN. PATELLA WAS REPLACED. DOI: UNKNOWN; DOR: (B)(6) 2018; UNKNOWN OPERATIVE SIDE.

  Patient problems: Pain

  MAUDE report 7323614 ↗
• InjuryNov 2, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6998311 ↗