SIGMA AOX 1961-92-143Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295076605), received between Oct 15, 2019 and Oct 15, 2021 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  QUESTIONS: 1. WAS THE CEMENT PRODUCT MANUFACTURED BY DEPUY? IF YES, PLEASE PROVIDE THE PART AND LOT NUMBERS AND QUANTITY OF THE CEMENT. 2. PLEASE CLARIFY, WAS THE PATELLAR IMPLANT REMOVED? 3. IT WAS INDICATED IN THE EVENT DESCRIPTION THAT PATIENT WAS REVISED WITH A THICKER POLY ON (B)(6) 2020. WAS THIS BEING REPORTED? IF YES, PLEASE PROVIDE THE COMPLAINT NUMBER. 3.1. IF NONE REPORTED, PLEASE PROVIDE DETAILS OF THE PREVIOUS REVISION. 4. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? 5. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? 6. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? 7. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY. ANSWERS: 1. UNKNOWN WHAT CEMENT. 2. PATELLA WAS RETAINED. 3. ORIGINAL CASE # WAS (B)(4). ( I AM ATTACHING THE MDR AS THERE IS NO COMPLAINT # ON IT. 5-7. NO OTHER THAN THAT, I HAVE NO FURTHER INFORMATION.

  Patient problems: Joint Laxity

  MAUDE report 12638394 ↗
• InjuryNov 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. POLY EXCHANGE WAS PERFORMED. DOI: (B)(6) 2018. DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9336553 ↗
• InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS FLEXION INSTABILITY. ONLY THE FEMORAL SIDE WAS REMOVED AND REPLACED WITH A TC3 PROSTHESIS. DOI: (B)(6) 2018; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9193698 ↗