SIGMA 1024-51-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295002345), received between Sep 29, 2020 and Jan 15, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (4 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.

• InjuryJan 15, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THERE WAS ASEPTIC LOOSENING OF A UNI. DOI: (B)(6) 2020. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Aseptic loosening

  MAUDE report 24085579 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR LATERAL COMPARTMENT PAIN. THE SURGEON MADE PRIMARY CUTS AND IMPLANTED A SIZE 5 FEMUR AND SIZE 7 TIBIAL TRAY WITH 12MM INSERT. THE LEFT MEDIAL UNI IMPLANTS WERE EXPLANTED. NO DELAY IN SURGERY AND NO INJURY TO THE PATIENT. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 23649914 ↗
• InjuryJun 19, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT HAD A UNI IN (B)(6) 2024. THE TIBIAL TRAY IS LOOSE AT THE CEMENT TO IMPLANT INTERFACE AND IT IS BEING REVISED TO A TOTAL KNEE. NO DELAYS. THE CEMENT MANUFACTURER IS COMPETITOR. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22292302 ↗
• InjuryFeb 16, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT EXPERIENCED ASEPTIC MOBILIZATION. DOI: (B)(6) 2021; DOE: (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 18721234 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR CONTINUED DRAINAGE. EXPLANTED SZ 4 LM FEMUR, THE SZ 4 LM TIBIAL TRAY AND SZ 4, 8MM TIBIAL INSERT. WASHOUT WAS CONDUCTED, ANTIBIOTICS ADMINISTERED. IMPLANTED A NEW SZ 4 LM FEMUR, AND A SZ 4,11MM INSERT. PREVIOUS WASHOUT ON (B)(6) 2022 RESULTED IN ONLY AN INSERT SWAP OUT. REPORT WAS CREATED. NO DELAY IN SURGERY. NO INJURY TO PATIENT. THIS WAS THE LEFT KNEE. ORIGINAL DOS WAS (B)(6) 2022. DOI: (B)(6) 2022, DOR: (B)(6) 2022, LEFT KNEE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 14690029 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT KNEE TKA EXPLANATION FOR INFECTION. CEMENT NOT FROM DEPUY. REVISION/REMOVAL OF HARDWARE COMPLETED.

  Patient problems: Unspecified Infection

  MAUDE report 13023423 ↗
• InjuryAug 18, 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 REPORTED. DOI: (B)(6) 2020. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Pain

  MAUDE report 12338650 ↗
• 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 11761143 ↗
• InjurySep 29, 2020Loss of or Failure to Bond; Malposition of Device; Loss of or Failure to Bond; Malposition of Device

  PATIENT UNDERWENT PRIMARY LM UNICOMPARTMENTAL KNEE REPLACEMENT ON (B)(6) 2019 WHERE A SIGMA PARTIAL WAS UTILISED ((B)(6)). PATIENT HAS REPORTED THAT THE KNEE HAS NEVER FELT TOTALLY GOOD. PATIENT HAS REPORTED ONGOING PAIN. X-RAYS INDICATE A POSSIBLE LOOSE TIBIAL COMPONENT WITH POSSIBLE SUB-OPTIMAL POSITIONING AT TIME OF INDEX SURGERY. A DECISION WAS MADE TO REVISE THE SIGMA PARTIAL TO A TOTAL KNEE ON (B)(6) 2020 ((B)(6) HOSPITAL). ON OPENING THE KNEE, THE TIBIAL TRAY WAS NOT WELL FIXED. ALL COMPONENTS WERE REMOVED AND A STEMMED TIBIAL COMPONENT (SLEEVE AND STEM) IMPLANTED ON THE TIBIAL SIDE AND A PRIMARY ATTUNE PS FEMUR ON THE FEMORAL SIDE. PATIENT STATUS/ OUTCOME / CONSEQUENCES: UNKNOWN, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? PAIN AND POSSIBLE TIBIAL LOOSENING, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: NO, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION

  Patient problems: No Code Available; Pain

  MAUDE report 10601071 ↗