SIGMA 1024-52-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295002406), received between Nov 25, 2017 and Nov 14, 2025 — classified as 11 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT HAD A RIGHT MEDIAL SIGMA PARTIAL PROCEDURE. PATIENT COMPLAINED OF PAIN. X-RAY WAS TAKEN AND RADIOLUCENT LINES WERE PRESENT UNDER THE TIBIAL IMPLANT. THE LOOSENING HAS OCCURRED DURING THE TIME AFTER THE PROCEDURE. KNEE WAS REVISED TO TOTAL KNEE REPLACEMENT WITH ATTUNE REVISION ON STANDBY.

  Patient problems: Pain

  MAUDE report 23557010 ↗
• InjuryApr 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LOOSE POLYETHYLENE WAS REMOVED AND REPLACED. IT APPEARED TO HAVE NOT BEEN FULLY SEATED AT INDEX SURGERY. THERE WAS NO SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 21878160 ↗
• MalfunctionJan 22, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A VELYS UNICOMPARTMENTAL KNEE (UKA) SYSTEM CASE, THE POST-OPERATIVE X-RAY SHOWED THAT THE TIBIAL COMPONENT WAS SITTING PROUDLY POSTERIORLY. THE SURGEON HAD CHECKED TESTED THE FIT USING THE SPACER BLOCK AND ALSO USING THE KEEL CHECKER WITH THE TIBIAL TEMPLATE AND DID NOT OBSERVE THE ISSUE AT THAT TIME. DOE: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21207298 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED. THE CHRONIC EFFUSION WAS THE ISSUE, FOR THE REVISION.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 19628855 ↗
• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN AND THE UNI KNEE WAS CONVERTED TO A TOTAL KNEE. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2022 DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17624777 ↗
• 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 15411055 ↗
• InjuryApr 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. TOTAL KNEE REVISION WAS DONE. DOI: (B)(6) 2015 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11676124 ↗
• 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 9900636 ↗
• InjuryNov 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO TIBIA PERIPROSTHETIC FRACTURE UNDER TIBIAL PLATE. THE SURGEON REMOVED UNI AND PERFORMED A TKA. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9384567 ↗
• InjuryAug 30, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE TIBIAL TRAY HAD A SLIGHT MEDIAL OVERHANG AT TIME OF INDEX SURGERY. IE THE TRAY THAT WAS IMPLANTED WAS A LITTLE LARGER ML THAN THE BONE BED AND THEREFORE HAD A 1-2MM OVERHANG MEDIALLY. THE AFFECTED SIDE IS THE RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8951278 ↗
• MalfunctionJul 10, 2019Device-Device Incompatibility; Device-Device Incompatibility

  TIBIAL INSERT FIXED BEARING UNICONDYLAR. SERIAL NUMBER ¿ (B)(4). LOT NUMBER ¿ J16X18. DATE OF MANUFACTURE ¿ 2018.12.11. DATE OF EXPIRY ¿ 2023.11.30. SERIAL NUMBER ¿ (B)(4). LOT NUMBER ¿ HJ0460. DATE OF MANUFACTURE ¿ 2017.10.23. DATE OF EXPIRY ¿ 2022.09.30. SERIAL NUMBER ¿ (B)(4). LOT NUMBER ¿ HJ4036. DATE OF MANUFACTURE ¿ 2017.10.30. DATE OF EXPIRY ¿ 2022.09.30. TIBIAL TRAY UNICONDYLAR METAL BACKED. SERIAL NUMBER ¿ (B)(4). LOT NUMBER ¿ HW7438. DATE OF MANUFACTURE ¿ 2018.05.16. DATE OF EXPIRY ¿ 2028.04.30. (B)(6) - PROLONGED PROCEDURE AND PROCEDURE CHANGE FROM PARTIAL KNEE REPLACEMENT TO A TOTAL KNEE REPLACEMENT.

  Patient problems: Not Applicable

  MAUDE report 8775549 ↗
• InjuryMay 29, 2019Device-Device Incompatibility; Device-Device Incompatibility

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

  Patient problems: Not Applicable

  MAUDE report 8649397 ↗
• 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 8649396 ↗
• InjuryNov 25, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 7058103 ↗