BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOULDER SYSTEM

    MDR report key: 22467162 · Received July 10, 2025

    Report

    Report Number
    3005180920-2025-00626
    Event Type
    Malfunction
    Date Received
    July 10, 2025
    Date of Event
    June 11, 2025
    Report Date
    July 10, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSD
    UDI-DI
    07630040728096
    PMA / PMN Number
    K193175
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11-06-2025 LOT 2400597: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-04-2024 EXPIRATION DATE: 2029-03-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. VISUAL INSPECTION PERFORMED BY R&D MANAGER: THE GLENOSPHERE PRESENTED ONLY MINOR MARKS AND SIGNS ON ITS TAPER CONNECTION WITH THE BASEPLATE, PROBABLY DUE TO THE FACT - AS DETAILED IN THE EVENT DESCRIPTION - THAT THE GLENOSPHERE AND THE BASEPLATE MATED CORRECTLY. THE CHAMFER AT THE END OF THE GLENOSPHERE PASS-THOROUGH HOLE PRESENTED MINOR SIGNS OF WEAR AND SOME DENTS. DURING VISUAL INSPECTION, THE SUBJECT DEVICE WAS COUPLED CORRECTLY AND WITHOUT ISSUES WITH A THREADED BASEPLATE Ø27. THE TWO AVAILABLE GLENOSPHERE SCREWS FROM THE COMPLAINT WERE FREE TO MOVE IN THE GLENOSPHERE HOLE, BOTH IN TRANSLATION AND ROTATION. THE GLENOSPHERE SCREWS PRESENTED BOTH MAJOR SCRATCHES AND USAGE MARKS: THE HEAD AND THE CYLINDRICAL PORTION WERE DISCOLORED. THE THREADED PORTION WAS HEAVILY DAMAGED IN BOTH SCREWS, PARTICULARLY IN THE FIRST 4 THREADS, THAT WERE COMPLETELY SMOOTHENED OUT. FROM THE MARKS ON THE SCREWS, A POSSIBLE ROOT CASE CAN BE TRACEABLE ON A MISALIGNEMENT OF THE GLENOSPHERE AND/OR SCREW INSERTION, POSSIBLY AT THE LEVEL OF THE GLENOSPHERE CHAMFER. THE DAMAGE ON THE THREAD LEAD TO THE DIFFICULTY OF SCREWING IN THE FOLLOWING TRIALS. OTHER DEVICES INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0177 GLENOSPHERE SCREW (K170452) LOT 2341007: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-11-2023 EXPIRATION DATE: 2028-10-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. THE ISSUE REPORTED MAY HAVE BEEN CAUSED BY A MISALIGNMENT BETWEEN THE GLENOSPHERE AND THE SCREW DURING INSERTION THAT LED TO THE DAMAGE OF THE SCREW THREAD PREVENTING SUBSEQUENT INSERTION ATTEMPTS BUT BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED WHILE THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    DURING TSA THE WHILE THE GLENSPHERE SEEMED CORRECTLY SEATED THE GLENOSPHERE SCREW GOT STUCK DURING INSERTION AND COULD NOT BE SCREWED IN, EVEN USING THE DEDICATED GLENOSPHERE GUIDE. THE SURGEON ALSO TRIMMED THE BONE AROUND THE BASEPLATE AND ATTEMPTED TO INSERT THE SCREW AGAIN TO NO AVAIL. A NEW SCREW WAS OPENED BUT ALSO THE SECOND SCREW COULD NOT BE SEATED. THE SURGEON THEN DECIDED TO CHANGE THE GLENOSPHERE WITH A NEW ONE, NOT HAVING ONE OF THE SAME REF IMPLANTED A STD. GLENOSPHERE 39XØ27 (REF. 04.01.0173). 45 MINUTES OF DELAY OVER A 4.5 HOURS SURGERY WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773886 SHOULDER SYSTEM REVERSE SHOULDER SYSTEM 04.01.0210 LAT. GLENOSPHERE 36XØ27 HSD MEDACTA INTERNATIONAL SA 04.01.0210 2400597 07630040728096

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Other