SIGMA 94-0015Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295223412), received between Feb 8, 2019 and Jul 3, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION OF PFC DUE TO LYSIS AND INSTABILITY. WHEN THE KNEE WAS OPENED, THE POLYETHYLENE HAD SOME UNNATURAL WEAR AND SIGNS OF LYSIS. CR FEMUR, POLYETHYLENE AND FB BASE WERE REMOVED. MINIMAL BONE LOSS ON TIBIAL SIDE. SOME BONE LOSE ON FEMORAL SIDE WHICH BONE GRAFT WAS USED TO CORRECT. PT HAD MINIMAL SIGNS OF INFECTION SO PROCEEDED TO IMPLANT ATTUNE REVISION. GOOD STABILITY ATTAINED WITH STEMS AND SLEEVES BOTH SIDES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 22398167 ↗
• InjuryOct 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RUPTURE OF MEDIAL ARTHROTOMY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. (LEFT KNEE) TREATMENT: SURGICAL INCISIONAL REPAIR OF ARTHROTOMY WOUND DEHISCENCE.

  Patient problems: Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 15691841 ↗
• InjuryJan 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS INSTABILITY DATE OF IMPLANTATION: (B)(6) 2011, DATE OF REVISION: (B)(6) 2021, (LEFT KNEE). TREATMENT: REVISION OF FEMUR AND TIBIAL INSERT; PATELLA WAS RESURFACED DURING REVISION; TIBIAL TRAY AND TIBIAL SLEEVE WERE RETAINED.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 13394372 ↗
• InjuryJul 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR WOUND DEHISCENCE OF INCISION; FALL RESULTING IN OPENING OF HIS SURGICAL INCISION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2020, (LEFT KNEE). TREATMENT: SURGICAL INTERVENTION WITH IRRIGATION AND DEBRIDEMENT.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 10269233 ↗
• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY ON (B)(6) 2020. ALL IMPLANTS WERE REMOVED AND AN FB TC3 WAS IMPLANTED. A PFC TOTAL KNEE REPLACEMENT WAS IMPLANTED APPROXIMATELY 3 MONTHS AGO.

  Patient problems: No Code Available

  MAUDE report 9813762 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL KNEE DONE IN 2013, PATIENT HAS FAILED THEIR KNEE OVER TIME AND HAS BECOME UNSTABLE. THE MISMATCH BETWEEN FLEXION AND EXTENSION PROVIDED TO BE TOO GREAT TO EXCHANGE THE POLY, THE KNEE WAS REMOVED AND AN ATTUNE REVISION KNEE WAS PLACED. DOI: (B)(6) 2013. DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9497715 ↗
• InjuryMay 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT LOWER EXTREMITY SUPERFICIAL THROMBOSIS AND CELLULITIS - REDNESS AND SWELLING. ONSET OCCURRED A FEW DAYS AFTER PRIMARY IMPLANT SURGERY. DOI: (B)(6) 2012, (LEFT KNEE).

  Patient problems: Cellulitis; Swelling; Thrombosis

  MAUDE report 8654011 ↗
• InjuryFeb 8, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT REVISION ON (B)(6) 2019. THE IMPLANT DATE WAS (B)(6) 2012. IT IS BELIEVED TO BE THE FIRST REVISION; FEMORAL COMPONENT AND BEARING REVISED PATELLA RESURFACED. PATHOLOGY DOES NOT INDICATE PRESENCE OF INFECTION CURRENTLY.

  Patient problems: Cyst(s); Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8322171 ↗