SIGMA AOX 1961-92-142Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295076599), received between Aug 30, 2017 and Jun 23, 2025 — 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 16, 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.

• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2010. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22308897 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD KNEE REPLACEMENT IN PA OVER 10 YEARS AGO. WAS BEING TREAT FOR SPINE INFECTION, THEN KNEE INFECTION. SURGEON PERFORMED A WASHOUT WITH POLY SWAP. NO OTHER INFO IN AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19222006 ↗
• InjuryAug 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SPOKE WITH PATIENT ON PHONE TODAY (B)(6) 2022. PATIENT STATES HIS PRIMARY WAS DONE IN (B)(6) , IN ON (B)(6) 2022 WITH DEPUY IMPLANTS. HE HAS NOW HAD A REVISION ON (B)(6) 2022. HE STATES THE TRAY WAS TILTED AND PRIOR TO THE REVISION, HE HAD PAIN AND DIFFICULTY WALKING. PART/LOT PROVIDED OF THE FEMORAL AND INSERT ARE BELOW. HE DID NOT HAVE ANY INFORMATION REGARDING THE TRAY. HE THEN REQUESTED COMPENSATION AND HIS INFORMATION HAS BEEN FORWARDED TO LEGAL (SEE (B)(4) LEGAL NOTIFICATION). HE WAS ALSO PROVIDED THE CONTACT INFORMATION OF THE LEGAL PARALEGAL. HE HAS NO FURTHER NEEDS AT THIS TIME. DOI: (B)(6) 2019; DOR: (B)(6) 2022; UNKNOWN SIDE.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Fatigue; Pain; Rash; Swelling/ Edema; Synovitis; Unspecified Infection

  MAUDE report 15311832 ↗
• InjuryJan 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF THE LEFT TOTAL KNEE TO ADDRESS INFECTION. DATE OF IMPLANTATION: (B)(6) 2017, DATE OF REVISION: (B)(6) 2021, (LEFT KNEE). TREATMENT: EXPLANTATION OF ALL IMPLANTS.

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

  MAUDE report 11251586 ↗
• InjuryJan 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT A BILATERAL KNEE REVISION DUE TO CONFIRMED INFECTION. IN ADDITION TO THE PREVIOUSLY REPORTED BILATERAL SWELLING, THE PATIENT WAS ALSO EXPERIENCING THE FOLLOWING BILATERAL KNEE ISSUES: PATELLA CLUNK, INSTABILITY, PAIN, DISCOMFORT, STIFFNESS, SYNOVITIS, EFFUSIONS, AND ADHESIONS. THE LEFT KNEE WAS NOTED TO SHOW OSTEOLYSIS UNDER THE PATELLA WHILE THE RIGHT KNEE SHOWED FEMORAL AND TIBIAL BONE LOSS.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Joint Laxity; Muscular Rigidity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 11230448 ↗
• InjuryJan 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT WAS NOTED TO HAVE A RIGHT TOTAL KNEE ARTHROPLASTY TO ADDRESS PRIMARY OSTEOARTHRITIS. DEPUY COMPONENTS INCLUDING DEPUY PATELLA AND DEPUY CEMENT WERE USED. THERE WERE NO COMPLICATIONS NOTED DURING THE PROCEDURE. ON (B)(6) 2021, THE PATIENT HAD BILATERAL STAGE ONE REVISION TO ADDRESS BILATERAL CHRONICALLY INFECTED TOTAL KNEE ARTHROPLASTIES. PRIOR TO SURGERY THE PATIENT WAS NOTED TO HAVE PAIN, SWELLING, CHRONIC CLUNK, STIFFNESS, AND DISCOMFORT WITH SIGNIFICANT SYNOVITIS AND EFFUSION. GRAM-POSITIVE COCCI WERE FOUND DURING PREOPERATIVE ASPIRATION. ALL COMPONENTS INCLUDING THE PATELLA WERE REVISED. DEPUY COMPONENTS INCLUDING DEPUY CEMENT WERE USED DURING THIS PROCEDURE. ON THE RIGHT SIDE, THE SURGEON NOTED A LITTLE BIT MORE BONE LOSS. NO OTHER COMPLICATIONS WERE NOTED. DEPUY COMPONENTS INCLUDING DEPUY CEMENT WERE USED FOR BOTH KNEES DURING THIS PROCEDURE.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Joint Laxity; Muscular Rigidity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 11222666 ↗
• InjuryAug 30, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  REPORT STATES THAT THE PATIENT WAS FEELING SOME DISCOMFORT. UPON OPENING THE KNEE SURGEON DECIDED THAT IT WAS BEST TO SWAP THE POLY AND TAKE SOME SYNOVIAL SAMPLES FOR LABS. SAME INSERT WAS INSERTED. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Discomfort

  MAUDE report 6833054 ↗