SIGMA AOX 1961-92-033Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295076186), received between Jun 22, 2017 and Feb 17, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD BILATERAL KNEE INFECTION. BOTH SIDES WERE SWAPPED OUT FOR NEW POLY. ON THE RIGHT SIDE, THERE WERE NO 3X17.5 RP CVD POLY AVAILABLE DUE TO BACK ORDER. THE POST WAS SHAVED OFF A 3X17.5 RPPS TO REPLICATE A CVD POLY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24364440 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD GLOBAL INSTABILITY. POLY WAS SWAPPED FROM 3X15 TO 3X20. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23598054 ↗
• InjuryJan 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: STUDY NO: CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INSTABILITY. DATE OF IMPLANT: (B)(6) 2016. DATE OF REVISION: (B)(6) 2024. (RIGHT KNEE). TREATMENT: INSERT WAS REVISED.

  Patient problems: Joint Laxity

  MAUDE report 18579202 ↗
• InjuryAug 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2023. DATE OF REVISION: (B)(6) 2023. (RIGHT KNEE). TREATMENT: INSERT WAS REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 17498203 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD INFECTION. JOINT WAS IRRIGATED AND DEBRIDEMENT (I&D), AND POLY WAS SWAPPED. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17450815 ↗
• InjuryNov 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR GLOBAL INSTABILITY OF THE LEFT KNEE EVENT IS SERIOUS, AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO BOTH DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2016; DATE OF EVENT (ONSET): (B)(6) 2020; (LEFT KNEE). TREATMENT: AWAITING REVISION SURGERY.

  Patient problems: Ambulation or Postural Difficulties; Fall; Joint Laxity; Pain

  MAUDE report 10905803 ↗
• InjuryJul 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AS PER SURGEON, THE PATIENT WAS EXPERIENCING FLEXION INSTABILITY. UNKNOWN IF ORIGINAL CASE OCCURRED AT THE (B)(6) HOSPITAL BUT THEIR OFFICE WAS ABLE TO TRACE THE LOT NUMBER FROM THE FEMUR TO THAT FACILITY AND DATE. THEY DO NOT HAVE PART NUMBER ON INSERT BUT KNOW IT WAS A SIGMA CR AOX SZ 15MM AND POTENTIAL LOT NUMBER IS 3472040. PATELLA ALSO RETAINED BUT NO PART NUMBERS. SURGEON REMOVED FEMUR, TIBIA, INSERT, AND REVISED TO ATTUNE REVISION. DOI: (B)(6) 2011. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10305492 ↗
• InjuryFeb 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A RUPTURED RETINACULUM PROBABLY DUE TO A FALL. WELL FIXED FEMUR WAS REVISED FOR STABILITY. DOI: 2015; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Fall; Injury; No Code Available

  MAUDE report 9745853 ↗
• InjuryJan 29, 2020Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT KNEE TO ADDRESS INFECTION. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF REVISION: (B)(6) 2019, (LEFT KNEE). TREATMENT: TIBIAL INSERT REVISED.

  Patient problems: Joint Disorder; Necrosis; No Code Available; Pain; Unspecified Infection; Wound Dehiscence

  MAUDE report 9643010 ↗
• InjuryJan 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL KNEE TO ADDRESS DEEP INFECTION (RIGHT KNEE).

  Patient problems: Abscess; No Code Available; Unspecified Infection

  MAUDE report 9608217 ↗
• InjuryJan 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION AND WAS WASHED OUT. THE POLY WAS SWAPPED. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Joint Contracture; Joint Disorder; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; Muscular Rigidity; Necrosis; No Code Available; Pain; Unspecified Infection; Wound Dehiscence

  MAUDE report 9586666 ↗
• InjuryApr 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND DEFINITELY NOT RELATED TO PROCEDURE. EXPLANT OF ALL COMPONENT FOR TWO-STAGE REVISION. DOI: (B)(6) 2016; DOE: (B)(6) 2018; DOR: (B)(6) 2018; (LEFT KNEE).

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7435722 ↗
• InjuryJun 22, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICAL DER STATES THAT AN AE WAS RECEIVED FOR INFECTION. EVENT MEETS THE DEFINITION OF SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. TREATMENT INCLUDES IRRIGATION AND DÉBRIDEMENT. EVENT IS CONSIDERED RESOLVED. UPDATE: JUN 05, 2017: THE PATIENT WAS REVISED TO ADDRESS INFECTION ON (B)(6) 2017. DEPUY INSERT WAS REVISED. THIS COMPLAINT WAS UPDATED ON JUN 14, 2017.

  Patient problems: Synovitis; Unspecified Infection

  MAUDE report 6662611 ↗
• InjuryJun 22, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6662519 ↗