SIGMA 1024-07-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295001737), received between Aug 17, 2017 and Aug 6, 2026 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50168274 ↗
• InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 13686022 ↗
• InjuryDec 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION UKA FOR ANTERO-MEDIAL TIBIAL IMPACTION DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES. HARDWARE/EXPLANT REMOVAL DUE TO: PAIN. IF YES, DATE OF REVISION SURGERY: (B)(6) 2021. REASON FOR REVISION SURGERY: PAIN.

  Patient problems: Pain

  MAUDE report 12953570 ↗
• InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY RIGHT LATERAL UNICOMPARTMENTAL KNEE REPLACEMENT ON (B)(6) 2008 WHERE A SIGMA PARTIAL WAS UTILISED. PATIENT HAS PRESENTED WITH A PROGRESSIVELY MORE PAINFUL KNEE AND HAS REPORTED FEELINGS OF INSTABILITY ON THE LATERAL SIDE. ON OPENING THE KNEE ((B)(6) 2021 (B)(6)) ALL COMPONENTS WERE FOUND TO BE WELL FIXED. REASON FOR REVISION WAS PROGRESSION OF DISEASE AND PAIN. COMPONENTS WERE REMOVED AND A RIGHT PRIMARY ATTUNE PS RP IMPLANTED.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11831661 ↗
• InjuryMay 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATED THAT THIS WAS DUE TO NATURAL PROGRESSION AND AN ACL TEAR. CEMENT USED WAS DEPUY GHV.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 11761147 ↗
• InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE REPORTED EVENT WAS DUE TO NATURAL PROGRESSION.

  Patient problems: No Code Available; Pain

  MAUDE report 8951795 ↗
• InjuryJan 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN AND WAS CONVERTED TO PRIMARY KNEE. DOI: (B)(6) 2011; DOR: (B)(6) 2018; UNKNOWN OPERATIVE SIDE.

  Patient problems: Pain

  MAUDE report 7224236 ↗
• InjuryJan 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION OF UNI KNEE; DR (B)(6), (B)(6) HOSPITAL (B)(6) 2017. PATIENT UNDERWENT PRIMARY UNICONDYLAR KNEE REPLACEMENT ON (B)(6) 2014 (DR (B)(6), (B)(6) HOSPITAL). PATIENT HAS DONE WELL UNTIL 3 MONTHS AGO WHEN THE KNEE BECAME PAINFUL, ESPECIALLY WHEN ROLLING OVER IN BED AT NIGHT. ON REVIEWING THE X-RAYS IT WAS SUSPECTED THAT THE TIBIAL TRAY MAY BE LOOSE. ON OPENING THE JOINT, THE TRAY APPEARED TO BE WELL FIXED, WITH NO OBVIOUS ISSUES (WEAR, LOOSE COMPONENTS ETC). THE UNI KNEE WAS REMOVED AND A PFC TC3 RP IMPLANTED. FEMALE PATIENT INITIALS (B)(6), AGED (B)(6) YEARS, DOB (B)(6) 1934.

  Patient problems: Pain

  MAUDE report 7171173 ↗
• InjuryAug 17, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING IN THE FEMORAL COMPONENT.

  Patient problems: Pain

  MAUDE report 6800964 ↗
• InjuryAug 17, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING IN THE FEMORAL COMPONENT.

  Patient problems: Pain

  MAUDE report 6800934 ↗