SIGMA 1960-79-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295075530), received between Nov 2, 2017 and Jan 14, 2022 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN. NO SURGICAL DELAY. DOI: (B)(6) 2018, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 13258912 ↗
• InjuryJul 6, 2021Use of Device Problem; Use of Device Problem

  ON (B)(6) 2018, THE PATIENT UNDERWENT A PRIMARY RIGHT KNEE ARTHROPLASTY TO ADDRESS DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED AND DEPUY PRODUCTS AND CEMENT X 2 WERE UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT KNEE REVISION TO ADDRESS PAIN, ADHESIONS, PATELLA MALTRACKING, AND MISPOSITIONING OF BOTH THE TIBIAL TRAY AND FEMORAL COMPONENT. THE SURGEON NOTED A FAIR AMOUNT OF FLUID IN THE KNEE, MINOR BONE LOSS THE FEMUR, AND VERY RED SUBCUTANEOUS TISSUE. NO EVIDENCE OF INFECTION. THE TIBIAL TRAY WAS NOTED TO BE SIGNIFICANTLY PLACED POSTERIORLY AS WELL AS SLIGHTLY INTERNALLY ROTATED TO THE TIBIAL TUBERCLE AND THE FEMORAL COMPONENT WAS ALSO SLIGHTLY INTERNALLY ROTATED. THE PATELLAR COMPONENT WAS STABLE. IT WAS FELT THE JOINT LINE HAD BEEN RAISED SIGNIFICANTLY BASED ON EVALUATION OF THE X-RAYS AS WELL AS OTHER EVIDENCE INTRA-OPERATIVELY. TO CORRECT THE PROBLEMS THE FEMORAL AND TIBIAL COMPONENTS WERE REVISED WITH THE GOAL OF SALVAGING THE PATELLAR COMPONENT. THE SURGEON RELEASED ADHESIONS IN THE SUPRAPATELLAR POUCH AND LATERAL GUTTER AND ATTEMPT TO MOBILIZE THE PATELLA LATERALLY. THE RESULT WAS A PATELLAR THAT TRA

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 12122920 ↗
• InjuryDec 21, 2020Off-Label Use; Off-Label Use

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER UNKNOWN. SURGEON NOTED CONSTRUCT WAS OFF LABEL: 4 RP PS FEMUR WITH 2.5 MBT TIBIA WAS EXPLANTED. IMPLANT DEBONDED FROM CEMENT MANTEL. NO SURGICAL DELAY. DOI: (B)(6) 2012, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 11049420 ↗
• InjuryJun 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS DISTAL FEMORAL FRACTURE. DOI: (B)(6) 2017 DOR: (B)(6) 2020 RIGHT KNEE.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10134049 ↗
• InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS FLEXION INSTABILITY. ONLY THE FEMORAL SIDE WAS REMOVED AND REPLACED WITH A TC3 PROSTHESIS. DOI: (B)(6) 2018; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9193694 ↗
• InjurySep 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS GROSS INSTABILITY. THE FEMUR WAS REVISED TO A HIGHER CONSTRAINT. DOI: (B)(6) 2017; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 8972020 ↗
• InjuryNov 2, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6998307 ↗