SIGMA 1024-53-407Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295002581), received between May 31, 2018 and Aug 18, 2026 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Difficult to Insert

  The tibial insert poly did not click/fit in the tibia tray. The surgeon tried a few times to insert the poly, cleared the knee of possible cement and soft tissue but the poly would not sit in the tibia tray.3 different polys were opened and only the 3rd one fit in.Was there any reported patient or user harm? No.Was there a significant delay? No.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50305027 ↗
• MalfunctionAug 18, 2026Difficult to Insert

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50304795 ↗
• MalfunctionJan 8, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE INSERT WOULD NOT LOCK INTO PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18464408 ↗
• 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 13023422 ↗
• 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 12338645 ↗
• InjuryApr 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF AN UNKNOWN COMPONENT. UNKNOWN CEMENT WAS USED. ON (B)(6) 2019, THE PATIENT UNDERWENT A PRIMARY LEFT KNEE ARTHROPLASTY WITH IMPLANTATION OF DEPUY UNICONDYLAR SLED PROTHESIS TO TREAT OSTEOARTHRITIS. DEPUY CEMENT WAS UTILIZED DURING THE PROCEDURE. THE PATELLA WAS NOT RESURFACED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2020, THE PATIENT UNDERWENT A LEFT KNEE REVISION TO ADDRESS PAIN, ADHESION, CYSTS, CREPITUS, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. ALL COMPONENTS WERE REMOVED, AND THE PATELLA WAS RESURFACED. DEPUY PRODUCTS WERE IMPLANTED WITH DEPUY CEMENT. ON (B)(6) 2021, A LEFT KNEE X-RAY REVEALED OSTEOLYSIS BENEATH THE TIBIAL PLATEAU. ON (B)(6) 2021, A LEFT KNEE CT REVEALED POSSIBLE TIBIAL TRAY LOOSENING. ON (B)(6) 2021, THE PATIENT UNDERWENT A LEFT KNEE ASPIRATION TO RULE OUT INFECTION DUE TO INCREASING PAIN. THE PHYSICIAN ASPIRATED 15 ML OF BLOOD-TINGED CLEAR EFFUSION AND SENT FOR MICROBIOLOGY AND CELL COUNT. RESULTS OF ASPIRATION NOT GIVEN WITHIN THE AVAILABLE MEDICAL RECORDS. THE PHYSICIAN ALSO INDICATED A REQUEST FOR ALLERGY TESTING FOR THE BONE CEMENT. NO RESULTS AVAILABLE R

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cyst(s); Pain

  MAUDE report 11619149 ↗
• MalfunctionApr 17, 2019Difficult to Insert; Device-Device Incompatibility; Difficult to Insert; Device-Device Incompatibility

  HP UNI FIXED BEARING INSERT DID NOT LOCK INTO THE TIBIAL TRAY ANTERIORLY. REPLACED THE FIRST INSERT WITH ANOTHER INSERT OF THE SAME SIZE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> YES, IF YES, NUMBER OF MINUTES: --> 3-5 MINUTES, ACTION TAKEN WHEN EVENT OCCURRED? --> REPLACED FIRST INSERT WITH REPLACEMENT , WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES, WERE FRAGMENTS GENERATED? --> NO, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO.

  Patient problems: Not Applicable

  MAUDE report 8523959 ↗
• InjuryJul 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH UNKNOWN REASON. DOI: UNKNOWN, DOR: (B)(6) 2018, LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7679372 ↗
• InjuryJun 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISED FOR I&D, INFECTION, WASHOUT. PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7629228 ↗
• InjuryJun 15, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED FOR INFECTION. REMOVED SZ4,7MM LM/RL UNI INSERT. WASHOUT KNEE AND IMPLANTED NEW UNI INSERT. SAME SIZE. PATIENT CONSEQUENCE? NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7604994 ↗
• MalfunctionMay 31, 2018Device-Device Incompatibility; Device-Device Incompatibility

  DER STATES THAT INSERT DID NOT SEEM TO ENGAGE PROPERLY. SECOND INSERT USED IN SAME MANNER SEATED PROPERLY. THREE MINUTES SURGICAL DELAY. DOI: (B)(6) 2018 LEFT KNEE.

  Patient problems: Not Applicable

  MAUDE report 7556586 ↗