SIGMA AOX 1961-92-124Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295076476), received between Dec 6, 2019 and Dec 10, 2021 — classified as 7 injuries.

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.

• InjuryDec 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO UNSTABLE KNEE SO THE DOCTOR PULLED OUT A 17.5 INSERT AND PUT IN A 22.5 MM INSERT. ORIGINAL IMPLANT DATE IS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12978130 ↗
• InjuryJul 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO CONFIRMED INFECTION. PATIENT ORIGINAL SURGERY WAS AT PVH ON (B)(6) 2019 WHEREBY PATIENT UNDERWENT A SIGMA COMPLEX PRIMARY CONSTRUCT WITH A PS SIGMA FEMUR, CEMENTED STEM AND A RP REV SIGMA TIBIA WITH CEMENTED STEM. PATIENT IS CONFIRMED FOR INFECTION TODAY AND ANOTHER POLY EXCHANGE WAS PERFORMED. PATIENT HAS A HISTORY ON POLY EXCHANGE RECENTLY 1 ON (B)(6) 2019 AND ONE ON (B)(6) 2020. TO BE CLEAR, PATIENT HAD THE I&D AND POLY SWAP PERFORMED TODAY (B)(6) 2020. DOI: (B)(6) 2020 DOR: (B)(6) 2020 LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10297733 ↗
• InjuryMay 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS AN INFECTION. KNEE WASHED OUT, I & D, AND THE POLY WAS EXCHANGED. DOI: (B)(6) 2019. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10102550 ↗
• InjuryFeb 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE DEEP INFECTION--STAPHYLOCOCCUS AUREUS, KNEE WASHOUT WITH POLY SWAP. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY IT IS RELATED PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019; DATE OF EVENT (ONSET): (B)(6) 2019; (LEFT KNEE).

  Patient problems: Edema; No Code Available; Pain; Unspecified Infection

  MAUDE report 9676811 ↗
• InjuryDec 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOI:(B)(6) 2019. PATIENT RECEIVED A LEFT TOTAL KNEE ARTHROPLASTY TO TREAT SEVERE RHEUMATOID ARTHRITIS, INSTABILITY, AND TIBIAL AND FEMORAL BONE LOSS SECONDARY TO ADVANCED OSTEOPOROSIS. DUE TO THE EXTENSIVE BONE LOSS, THE SURGEON IMPLANTED A DEPUY REVISION KNEE WITH PATELLAR RESURFACING AND DEPUY CEMENT FOR THE PRIMARY PROSTHESIS. PRIMARY OPERATIVE NOTES CONFIRM MASSIVE TIBIAL AND FEMORAL BONE LOSS DUE TO ADVANCED OSTEOPOROSIS. DOR: (B)(6) 2019. PATIENT REFERRED FOR AN INCISION AND DEBRIDEMENT WITH TIBIAL INSERT EXCHANGE TO TREAT PAIN AND SWELLING SECONDARY TO AN INFECTION. THE INFECTION WAS CONFIRMED INTRAOPERATIVELY. A DEPUY TIBIAL INSERT WAS IMPLANTED AT REVISION. THE PATIENT WAS PLACED ON LONG-TERM SUPPRESSIVE ORAL ANTIBIOTIC THERAPY.

  Patient problems: Edema; No Code Available; Pain; Unspecified Infection

  MAUDE report 9476353 ↗
• InjuryDec 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. DOI: (B)(6) 2019. DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9476083 ↗
• InjuryDec 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS STIFFNESS. DOI: (B)(6) 2018. DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9425294 ↗