SIGMA 1024-56-207Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295501800), received between Mar 27, 2023 and Sep 4, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS ABOUT THE INITIAL SURGERY AND PAIN AFTER THE SURGERY. THIS PC REPORTS ABOUT THE REVISION SURGERY. IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN INITIAL SURGERY VIA UKA FOR OA ON MEDIAL CONDYLE OF RIGHT KNEE WITH THE PRODUCTS IN QUESTION. IN THE INITIAL SURGERY, A STANDARD HPP INTUITION MACHINE WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE INITIAL SURGERY, DURING A POSTOPERATIVE VISIT, THE PATIENT COMPLAINED OF PAINFUL DISCOMFORT. WHEN THE KNEE WAS EXTENDED AFTER DEEP FLEXION, THERE WAS A SYMPTOM LIKE A CRACKING SOUND. THAT SYMPTOM DID NOT OCCUR WHEN THE EXTENSION WAS PERFORMED FROM INTERMEDIATE FLEXION. IT WAS THOUGHT THAT THE INSERT WAS NOT DISLODGED, BUT RATHER THAT THE SOFT TISSUE WAS IMPINGING SOMEWHERE. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2025. AFTER REMOVING THE INSERT AND CHECKING THE SOFT TISSUE, A CEMENT FRAGMENT WAS EXTRACTED FROM THE REAR (THE CEMENT WAS OTHER COMPANIES' PRODUCTS). THIS WAS THOUGHT TO BE THE CAUSE, BUT IT WAS DISCOVERED THAT THE FE IMPLANT HAD LOOSENED, AND IT WAS REMOVED USING A KOCHER CLAMP. USING A 3-IN-1 CUT BLOCK (SRI), INSERT TWO BLOCK STABILIZE

  Patient problems: Discomfort; Pain

  MAUDE report 22965333 ↗
• InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH POLY EXCHANGE DUE TO INFECTION. SURGICAL DELAY UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16823881 ↗
• InjuryApr 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON PERFORMED A KNEE SCOPE AND WASHOUT TO RETRIEVE LOOSE BODY. EXTRACTED THE SZ 2, 7MM UNI TIBIAL INSERT. REMOVED LOOSE BODY AND IMPLANTED A NEW SZ 2, 7MM UNI TIBIAL INSERT. NO DELAY IN SURGERY. NO INJURY TO PATIENT. DOI: (B)(6) 2022. DOR: (B)(6) 2023. LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16794901 ↗
• MalfunctionMar 27, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT TIBIAL INSERT WOULD NOT SEAT IN METAL TRAY. AFTER SEVERAL ATTEMPTS A NEW INSERT WAS OPENED AND SUCCESSFULLY INSERTED. THERE WAS A SURGICAL DELAY OF 2 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 16617761 ↗