SIGMA 1024-51-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295002321), received between Jan 29, 2018 and Jul 14, 2022 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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. How this data works · Data updated Oct 13, 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.

• InjuryJul 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AS TIBIA PLATEAU ENFORCEMENT. DOI: UNKNOWN. DOR: (B)(6) 2022. UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 15013574 ↗
• 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 13686016 ↗
• 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 12953618 ↗
• InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS KNEE PAIN. NO SURGICAL DELAY. DOI: (B)(6) 2016; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 12240298 ↗
• InjuryApr 22, 2021Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  REVISION OF A DEPUY SIGMA UNI KNEE REPLACEMENT. REASON FOR REVISION WAS DUE TO MEDIAL COLLAPSE/LOOSENING OF IMPLANTS. ALL IMPLANTS WERE REMOVED AND AN ATTUNE TOTAL KNEE WAS IMPLANTED. IMPLANTS NOT AVAILABLE FOR RETURN.

  Patient problems: Insufficient Information

  MAUDE report 11711684 ↗
• InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN AND WEARING DOWN THE LATERAL COMPARTMENT OF THE LEFT KNEE. SURGEON REMOVED THE UNI COMPONENTS AND REPLACED WITH A TOTAL KNEE. NO ACCESS TO THE CEMENT USED BUT KNOW IT WAS A 20G BATCH OF FAST SETTING BONE CEMENT. DOI: (B)(6) 2018 DOR: (B)(6) 2019 LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8951802 ↗
• InjuryOct 18, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  PATIENT WAS REVISED TO ADDRESS SUBSIDENCE AND LOOSENING OF THE TIBIAL COMPONENT AT THE BONE TO CEMENT INTERFACE.

  Patient problems: Failure of Implant

  MAUDE report 7980616 ↗
• 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 7224228 ↗