BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOUCH CMC 1 PROSTHESIS

    MDR report key: 23497041 · Received November 7, 2025

    Report

    Report Number
    3024706750-2025-00003
    Event Type
    Injury
    Date Received
    November 7, 2025
    Date of Event
    August 4, 2025
    Report Date
    September 10, 2025
    Manufacturer
    KERI MEDICAL SA
    Product Code
    SFA
    UDI-DI
    07640181160099
    PMA / PMN Number
    P240020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MATERIAL ANALYSIS (VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTIONS) COULD NOT BE CONFIRMED, SINCE THE AFFECTED DEVICE WAS NOT RETURNED. THE DEVICE AND THE COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS THE DEVICE LOT DETAILS WERE NOT PROVIDED. BASED ON THE PROVIDED MEDICAL IMAGING, THE FAILURE APPEARS TO BE PRIMARILY RELATED TO INADEQUATE BONE QUALITY AND QUANTITY (SMALL TRAPEZIUM), WHICH CONSTITUTES A CONTRAINDICATION TO IMPLANTATION. THE PATIENT DID NOT COMPLY WITH POSTOPERATIVE RECOMMENDATIONS, AS IMMOBILIZATION - ORIGINALLY PRESCRIBED FOR FOUR WEEKS - WAS DISCONTINUED AFTER ONLY SEVEN DAYS. THIS PREMATURE DISCONTINUATION LIKELY CONTRIBUTED TO IMPAIRED OSSEOINTEGRATION.

    Description of Event or Problem · 0

    THE PATIENT IS A 60-YEAR-OLD ACTIVE MALE (DOB: (B)(6) 1965, WEIGHT UNKNOWN) WHO UNDERWENT SURGERY ON (B)(6) 2025, DURING WHICH BONE GRAFTS WERE REQUIRED TO PLACE THE CUP DUE TO A CYST; POSTOPERATIVE IMMOBILISATION WAS PLANNED FOR 4 WEEKS BUT WAS DISCONTINUED BY MISTAKE AFTER 7 DAYS. AT A STANDARD POSTOPERATIVE CONTROL VISIT, THE PATIENT REPORTED NO PAIN OR DYSFUNCTION BUT X-RAYS SHOWED CUP MIGRATION AND TRAPEZIUM FRACTURE. ON (B)(6) 2025, A REVISION SURGERY WAS PERFORMED WITH THE SALES REPRESENTATIVE PRESENT; NO METALLOSIS WAS OBSERVED, THE CUP HAD MIGRATED FROM THE TRAPEZIUM INTO THE SURROUNDING TISSUE, AND THE TRAPEZIUM WAS FRACTURED IN THE MIDDLE, PREVENTING PLACEMENT OF A NEW CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1848644 TOUCH CMC 1 PROSTHESIS TOUCH® - CMC1 PROSTHESIS CONICAL CUP Ø9MM SFA KERI MEDICAL SA TOUCH® - CMC1 PROSTHESIS CONICAL CUP Ø9MM 07640181160099

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention