BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAFITCUP CC CUP IMPACTOR

    MDR report key: 4373098 · Received December 9, 2014

    Report

    Report Number
    3005180920-2014-00177
    Event Type
    Malfunction
    Date Received
    December 9, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS: FROM THE DOCUMENT REVIEW OF THE LOT INVOLVED (1110483-218 INSTRUMENTS PRODUCED) NO ANOMALIES WERE FOUND. NO SIMILAR ISSUES HAVE BEEN REGISTERED WITH ITEMS OF THE SAME LOT. VERSAFITCUP CC TRIO NO HOLES SHELL ((B)(4)): CODE (B)(4).1154 LOT 144708:(B)(4) SHELLS MANUFACTURED AND 71 ALREADY SOLD. NO ANOMALIES WERE FOUND FROM THE DOCUMENT REVIEW; NO SIMILAR CASES WITH ITEMS OF THE SAME LOT. THE FAILURE MODE IS UNLIKELY TO CAUSE PATIENT HARM, EVEN IF IT CAN LEAD TO ADDITIONAL STEPS TO FIX THE PROBLEM.

    Description of Event or Problem · 1

    THE IMPACTOR WAS STUCK IN THE SHELL. THE SURGEON HAD TO CHANGE THE CUP TO COMPLETE THE SURGERY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797219 VERSAFITCUP CC CUP IMPACTOR REUSABLE SURGICAL INSTRUMENT FOR HIP LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1