SIGMA AOX 1961-92-034Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295076193), received between Nov 29, 2017 and Oct 29, 2024 — classified as 8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID:(B)(6) STUDY NO: DOTS: CLINICAL ADVERSE EVENTS RECEIVED FOR CONTINUED PAIN, PINCHING SENSATION DEVICE AND PROCEDURE(RELATEDNESS) DEVICE RELATED: POSSIBLY PROCEDURE RELATED: REMOTE POSSIBILITY DATE OF EVENT: 8/OCT/2024 DATE OF IMPLANT: NO INFORMATION PROVIDED DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: SURGICAL EXPLORATION OF THE FEMUR AND DEBRIDEMENT OF THE FAT PAD DEPUY COMPONENTS USED IN PROCEDURE WITHOUT DATE OF REVISION: CATALOG ID: 129433130 LOT ID: 9744770 COMPONENT TYPE: TIBIAL DESCRIPTION: MBT CEMENTED KEEL SZ 3. CATALOG ID: 940023 LOT ID: J50C75 COMPONENT TYPE: FEMORAL DESCRIPTION: SIGMA FEM C/RET POROCOAT SZ 3 RT. CATALOG ID: 960101 LOT ID: D20101506 COMPONENT TYPE: PATELLAR DESCRIPTION: SIGMA PATELLA OVAL DOME 3 PEGGED 35MM. CATALOG ID: 3322020 LOT ID: 9524034 COMPONENT TYPE: CEMENT DESCRIPTION: SMART SET BONE CEMENT 20G. CATALOG ID: 3322020 LOT ID: 9448053 COMPONENT TYPE: CEMENT DESCRIPTION: SMART SET BONE CEMENT 20G. CATALOG ID: 196192034 LOT ID: 9137529 COMPONENT TYPE: INSERT DESCRIPTION: AOX CVD RP TIBIAL INSERT SZ 3 17.5MM. THE PATIENT STATUS POST: RIGHT KNEE REPLACEMENT/REVISION KNEE REPLACEMENT. THE PATIENT INITIA

  Patient problems: Discomfort; Numbness; Pain; Paresthesia

  MAUDE report 20559052 ↗
• InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 19343314 ↗
• InjurySep 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). DOTS. CLINICAL NOTIFICATION RECEIVED FOR RIGHT TOTAL KNEE REVISION TO ADDRESS INFECTION. DATE OF IMPLANTATION: (B)(6) 2018; DATE OF EVENT: (B)(6) 2019; (RIGHT KNEE).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9079344 ↗
• InjurySep 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A FIRST TIBIAL INSERT REVISION. FOLLOW-UP PERFORMED FOR REASON FOR REVISION. DOI: (B)(6) 2018. DOR: (B)(6) 2018. RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9070972 ↗
• InjurySep 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED FOR INFECTION. A CEMENT MOLD SPACER WAS IMPLANTED AFTER AN I&D WASHOUT. ANTIBIOTIC BEADS WERE USED. DOI: (B)(6) 2018. (B)(6) 2018 (INSERT). DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9040650 ↗
• InjurySep 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJ: (B)(4). ASSOCIATED STUDY: ROTATING PLATFORM DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR DELAYED WOUND HEALING (SUPERFICIAL SUBCUTANEOUS DYSVASCULAR CHANGES WITH ESCHAR AND DELAYED HEALING) AND SUBSEQUENT REVISION RELATED TO INFECTION AND WOUND BREAKDOWN. EVENT IS SERIOUS AND IS CONSIDERED MILD IN SEVERITY. EVENT IS NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DOI: (B)(6) 2018; DOE: (B)(6) 2018; DOR: (B)(6) 2018; (RIGHT KNEE). PATIENT PLACED ON KEFLEX 500MG QID AND UNDERWENT REVISION SURGERY WITH INSERT EXCHANGE. EVENT IS CONSIDERED RESOLVED AS OF (B)(6) 2018.

  Patient problems: Impaired Healing; Injury; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 7864806 ↗
• InjuryAug 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENTS KNEE BECAME INFECTED AND A WASH OUT WAS PERFORMED. ALL CEMENTED COMPONENTS WERE WELL FIXED AND NO INDICATION OF LOOSENING WAS OBSERVED. SURGEON WASHED THE JOINT OUT AND SWAPPED THE SIGMA CVD INSERT OUT WITH THE ORIGINAL SIZE AND THICKNESS INSERT. DOI: UNKNOWN ; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7823097 ↗
• InjuryNov 29, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT HAD AN MCL INJURY AFTER THE ORIGINAL TKA. THE MCL WAS REPAIRED AND A THICKER INSERT WAS PUT IN ON (B)(6) 2016. THE PATIENT HAD PAIN AND INSTABILITY SOME TIME AFTER THE MCL, SO THE IMPLANTS WERE REMOVED AND A REV CONSTRUCT WAS IMPLANTED.

  Patient problems: Pain

  MAUDE report 7069897 ↗