SIGMA AOX 1961-92-153Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295076674), received between Dec 2, 2019 and Nov 13, 2023 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS REVISED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6), 2020. DOR; (B)(6), 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 18123278 ↗
• InjuryMay 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY EXCHANGE WAS DONE FOR UNKNOWN INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 16843772 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTES INDICATE THAT ON (B)(6) 2023 THE PATIENT HAD A LEFT KNEE ASPIRATION: MEDICAL RECORDS REPORT THAT INFLAMMATION MARKERS WERE SLIGHTLY ELEVATED WITH A SEDIMENTATION RATE OF 43 AND C-REACTIVE PROTEIN IS 28. THE PATIENT¿S LEG IS NOTED TO BE SWOLLEN AND THE PATIENT REPORTS HAVING PAIN. THERE IS MODERATE EFFUSION. THE PATIENT REPORTED THAT THEY HAD A TRAUMA WHERE THEY WERE HANGING FROM HIS KNEE FOR AN HOUR, SO THE SWELLING COULD BE HEMARTHROSIS AND SECONDARY SYNOVITIS. THE PATIENT IS ON ANTIBIOTICS AND AN ASPIRATION WAS ORDERED. ON (B)(6) 2023, MEDICAL RECORDS NOTE THE PATIENT¿S KNEE IS INFECTED WITH STAPH. THE SURGEON IS PLANNING ON DOING A POLY SWAP WITH IRRIGATION. THE CLINICAL DATABASE INDICATES A REVISION OF THE LEFT KNEE WAS COMPLETED ON (B)(6) 2023 AS A TREATMENT FOR INFECTION. THE INSERT WAS REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 16742588 ↗
• InjuryAug 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S PRIMARY KNEE WAS REVISED DUE TO INFECTION. DURING THE REVISION PROCEDURE, ALL OF THE SIGMA PRIMARY COMPONENTS WERE REMOVED. THE PATIENT'S KNEE WAS THEN THOROUGHLY IRRIGATED AND DEBRIDED. A REPLACEMENT SIGMA PS FEMUR AND A REPLACEMENT SIGMA PS ALL POLY TIBIA WERE THEN IMPLANTED. THE PATIENT'S PATELLA WAS LEFT UNSURFACED. THE CEMENT MANUFACTURER WAS UNKNOWN. DOI: 2010. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15278100 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PATELLA CLUNK SYNDROME. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. THERE IS A REMOTE POSSIBILITY THE EVENT IS RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2013, DATE OF EVENT (ONSET): (B)(6) 2021, (LEFT KNEE). TREATMENT: SURGICAL ARTHROSCOPY OF THE LEFT KNEE (NO PRODUCTS REVISED).

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Pain

  MAUDE report 12373945 ↗
• InjuryDec 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. SURGEON PERFORMED I&D AND POLY EXCHANGE. THE SIGMA 5X15 RP INSERT WAS REMOVED AND REPLACED WITH 5X17.5 SIGMA RP INSERT. DOI: (B)(6) 2019. DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9399631 ↗