P.F.C. SIGMA 96-0883Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295234395), received between Nov 2, 2017 and Jan 12, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT A FEMORAL REVISION PERFORMED DUE TO LOOSENING OF THE FEMORAL COMPARTMENT. LOOSING OCCURRED AT THE FEMORAL ADAPTER AND SLEEVE JUNCTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2016. DOE: (B)(6) 2025. AFFECTED SIDE: RIGHT.

  Patient problems: Insufficient Information

  MAUDE report 24039343 ↗
• InjuryJan 12, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT A FEMORAL REVISION PERFORMED DUE TO LOOSENING OF THE FEMORAL COMPARTMENT. LOOSING OCCURRED AT THE FEMORAL ADAPTER AND SLEEVE JUNCTION. THERE WAS NO SURGICAL DELAY. DOI: ON (B)(6) 2016, DOE: ON (B)(6) 2025, AFFECTED SIDE: RIGHT.

  Patient problems: Insufficient Information

  MAUDE report 24039339 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN AND STERLING AND WAS TESTED FOR NICKEL ALLERGY. THE TEST CAME BACK POSITIVE SO THE SURGEON TOOK IT ALL OUT AND PUT IN AN AESCULAP REVISION CONSTRUCT. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 16585117 ↗
• InjuryDec 22, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE UNKNOWN COMPONENT AT THE UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE PATIENT BROKE THE ADAPTOR AND ADAPTOR BOLT FOR THE SECOND TIME. BONE HAS RESORBED AROUND THE IMPLANT CREATING ALMOST A DISTAL FEMORAL REPLACEMENT SITUATION. ADAPTOR BOLT, ADAPTOR, FEMORAL COMPONENT AND INSERT WERE REMOVED LEAVING THE TIBIAL COMPONENT AND FEMORAL SLEEVE AND STEM WELL FIXED IN THE PATIENT. A HINGED COMPONENT WAS THEN PREPPED FOR AND IMPACTED INTO THE SLEEVE THAT WAS WELL FIXED IN THE BONE AND A LPS INSERT WAS INSERTED. DOI: (B)(6) 2017. DOR: (B)(6) 2022. RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16033316 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED DUE TO INFECTION AND LOOSENING OF THE FEMORAL & TIBIAL COMPONENT AT THE BONE TO CEMENT INTERFACE. UNKNOWN CEMENT WAS USED. REMOVAL OF ALL IMPLANTS DUE TO CEMENT COULDN'T SEE MOST NUMBERS. ONLY ABLE TO OBTAIN THE NUMBERS FROM FEMORAL STEM, TC3 RP INSERT AND THE THICK TRAY. ALL OTHER PARTS WERE COVERED BY CEMENT. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2015 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12517249 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED DUE TO INFECTION AND LOOSENING OF THE FEMORAL & TIBIAL COMPONENT AT THE BONE TO CEMENT INTERFACE. UNKNOWN CEMENT WAS USED. REMOVAL OF ALL IMPLANTS DUE TO CEMENT COULDN'T SEE MOST NUMBERS. ONLY ABLE TO OBTAIN THE NUMBERS FROM FEMORAL STEM, TC3 RP INSERT AND THE THICK TRAY. ALL OTHER PARTS WERE COVERED BY CEMENT. NO FURTHER INFORMATION IS AVAILABLE. DOI:(B)(6) 2015 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12517243 ↗
• InjurySep 16, 2019Loss of or Failure to Bond; Malposition of Device; Migration; Loss of or Failure to Bond; Malposition of Device; Migration

  CLINICAL ADVERSE EVENT RECEIVED FOR LOOSENING OF BOTH FEMORAL AND TIBIAL COMPONENTS : ABNORMAL RADIOGRAPHIC EVALUATION EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DOI: (B)(6) 2002, DOR: (B)(6) 2009, DOE: (B)(6) 2019, (RIGHT KNEE). DATE OF INITIAL ONSET: (B)(6) 2017 LOOSENING OF THE TIBIAL COMPONENT: MIGRATION/LOOSENING - TIBIAL.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); No Code Available; Pain; Swelling; Synovitis

  MAUDE report 9071571 ↗
• InjuryOct 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY.

  Patient problems: No Code Available; Pain

  MAUDE report 7985930 ↗
• InjuryMay 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS KNEE INFECTION. IMPLANTS EXTRACTED AND ANTIBIOTIC SPACER WAS IMPLANTED. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7476945 ↗
• InjuryDec 1, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  REASON FOR REVISION - PAIN AND LACK OF EXTENSION. ORIGINAL SURGERY (B)(6) 2017.

  Patient problems: Pain

  MAUDE report 7075334 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING IMPLANTS WERE REMOVED TODAY DURING KNEE REVISION SURGERY AT (B)(6) HOSPITAL BY MR (B)(6). ORIGINAL SURGERY (B)(6) 2017. REASON FOR REVISION - PAIN AND LACK OF EXTENSION.

  Patient problems: Joint Disorder; Pain

  MAUDE report 7071274 ↗
• InjuryNov 3, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS PAIN, INSTABILITY AND LOOSENING OF THE FEMUR AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT IS USED.

  Patient problems: Pain

  MAUDE report 6999826 ↗
• InjuryNov 2, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIA AND FEMORAL COMPONENT AT THE BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACE, COMPETITOR CEMENT WAS USED.

  Patient problems: No Code Available

  MAUDE report 6998454 ↗