SIGMA 1024-54-408Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295002895), received between May 29, 2019 and Sep 13, 2022 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF UNI-KNEE IMPLANT CONSTRUCTS. PATIENT HAD UNI-COMPARTMENTAL KNEE REPLACEMENT ON THE RIGHT MEDIAL SIDE IN 2021. POST OPERATIVELY THE PATIENT EXPERIENCED CONSISTENT MEDIAL COMPARTMENT KNEE PAIN. THEREFORE A DECISION WAS MADE TO REMOVE THE UNI-COMPARTMENTAL CONSTRUCT AND IMPLANT A FULL ATTUNE PRIMARY KNEE CONSTRUCT. DOI: UNKNOWN, DOR: (B)(6) 2022, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15411013 ↗
• MalfunctionMar 30, 2020Difficult to Insert; Difficult to Insert

  WHILE OPERATING ORIGINAL INSERT DID NOT LOCK, SURGEON TRIED MANY TIMES THEN WE TAKE OUT AND INSERT THE ANOTHER ONE WHICH GOT LOCKED IN VERY FIRST GO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9900587 ↗
• InjuryMar 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. NO LOOSENING AND NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2020. DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9832250 ↗
• MalfunctionJul 10, 2019Device-Device Incompatibility; Device-Device Incompatibility

  TIBIAL INSERT FIXED BEARING UNICONDYLAR SERIAL NUMBER ¿ (B)(4), LOT NUMBER ¿ J16X18, DATE OF MANUFACTURE ¿ 12/11/2018, DATE OF EXPIRY ¿ 11/30/2023. SERIAL NUMBER ¿ (B)(4), LOT NUMBER ¿ HJ0460, DATE OF MANUFACTURE ¿ 10/23/2017, DATE OF EXPIRY ¿ 09/30/2022. SERIAL NUMBER ¿ (B)(4), LOT NUMBER ¿ HJ4036, DATE OF MANUFACTURE ¿ 10/30/2017, DATE OF EXPIRY ¿ 09/30/2022. TIBIAL TRAY UNICONDYLAR METAL BACKED SERIAL NUMBER ¿ (B)(4), LOT NUMBER ¿ HW7438, DATE OF MANUFACTURE ¿ 05/16/2018, DATE OF EXPIRY ¿ 04/30/2028. (B)(6) CENTRE: PROLONGED PROCEDURE AND PROCEDURE CHANGE FROM PARTIAL KNWW REPLACEMENT TO A TOTAL KNEE REPLACEMENT.

  Patient problems: Not Applicable

  MAUDE report 8775550 ↗
• MalfunctionJul 10, 2019Device-Device Incompatibility; Device-Device Incompatibility

  TIBIAL INSERT FIXED BEARING UNICONDYLAR: SERIAL NUMBER ¿ (B)(4), LOT NUMBER ¿ J16X18, DATE OF MANUFACTURE ¿ 12/11/2018, DATE OF EXPIRY ¿ 11/30/2023. SERIAL NUMBER ¿ (B)(4), LOT NUMBER ¿ HJ0460, DATE OF MANUFACTURE ¿ 10/23/2017, DATE OF EXPIRY ¿ 09/30/2022. SERIAL NUMBER ¿ (B)(4), LOT NUMBER ¿ HJ4036, DATE OF MANUFACTURE ¿ 10/30/2017, DATE OF EXPIRY ¿ 09/30/2022. TIBIAL TRAY UNICONDYLAR METAL BACKED: SERIAL NUMBER ¿ (B)(4), LOT NUMBER ¿ HW7438, DATE OF MANUFACTURE ¿ 05/16/2018, DATE OF EXPIRY ¿ 04/30/2028. (B)(6) CENTRE - PROLONGED PROCEDURE AND PROCEDURE CHANGE FROM PARTIAL KNWW REPLACEMENT TO A TOTAL KNEE REPLACEMENT.

  Patient problems: Not Applicable

  MAUDE report 8775548 ↗
• MalfunctionJul 10, 2019Device-Device Incompatibility; Device-Device Incompatibility

  TIBIAL INSERT FIXED BEARING UNICONDYLAR: SERIAL NUMBER ¿ (B)(4), LOT NUMBER ¿ J16X18, DATE OF MANUFACTURE ¿ 12/11/2018, DATE OF EXPIRY ¿ 11/30/2023. SERIAL NUMBER ¿ (B)(4), LOT NUMBER ¿ HJ0460, DATE OF MANUFACTURE ¿ 10/23/2017, DATE OF EXPIRY ¿ 09/30/2022. SERIAL NUMBER ¿ (B)(4), LOT NUMBER ¿ HJ4036, DATE OF MANUFACTURE ¿ 10/30/2017, DATE OF EXPIRY ¿ 09/30/2022. TIBIAL TRAY UNICONDYLAR METAL BACKED: SERIAL NUMBER ¿ (B)(4), LOT NUMBER ¿ HW7438, DATE OF MANUFACTURE ¿ 05/16/2018, DATE OF EXPIRY ¿ 04/30/2028. (B)(6) CENTRE - PROLONGED PROCEDURE AND PROCEDURE CHANGE FROM PARTIAL KNWW REPLACEMENT TO A TOTAL KNEE REPLACEMENT.

  Patient problems: Not Applicable

  MAUDE report 8775547 ↗
• InjuryMay 29, 2019Difficult to Insert; Device-Device Incompatibility; Difficult to Insert; Device-Device Incompatibility

  INSERT TO SEAT, OPENED ALTERNATIVE INSERTS ALL FAILED TO SEAT. REVISED IMPLANTS TO A TOTAL.

  Patient problems: Not Applicable

  MAUDE report 8649416 ↗
• InjuryMay 29, 2019Difficult to Insert; Device-Device Incompatibility; Difficult to Insert; Device-Device Incompatibility

  INSERT TO SEAT, OPENED ALTERNATIVE INSERTS ALL FAILED TO SEAT. REVISED IMPLANTS TO A TOTAL.

  Patient problems: Not Applicable

  MAUDE report 8649414 ↗
• InjuryMay 29, 2019Difficult to Insert; Device-Device Incompatibility; Difficult to Insert; Device-Device Incompatibility

  INSERT TO SEAT, OPENED ALTERNATIVE INSERTS ALL FAILED TO SEAT. REVISED IMPLANTS TO A TOTAL.

  Patient problems: Not Applicable

  MAUDE report 8649413 ↗