BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERMINAL CUP IMPACTOR FOR METAL BACK CC

    MDR report key: 4908860 · Received July 9, 2015

    Report

    Report Number
    3005180920-2015-00140
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Report Date
    October 7, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LXH
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 07 SEPTEMBER 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON THE SAME DAY THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2015: LOT #1413789: (B)(4) INSTRUMENTS MANUFACTURED AND RELEASED ON (B)(4) 2014. NO ANOMALIES FOUND RELATED TO THE PROBLEM. LOT #150076: (B)(4) SHELLS MANUFACTURED AND RELEASED ON (B)(4) 2015. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) SHELLS OF THE LOT HAVE BEEN ALREADY SOLD. ON (B)(6) 2015, THE (B)(4) MADE THE FOLLOWING ANALYSIS UPON INSPECTION OF THE RETRIEVED ITEMS: THE TERMINAL WAS MANUALLY DISENGAGED FROM THE CUP WITH THE SCREWDRIVER USING A CLAMP TO HOLD THE CUP. THE CONTACT SURFACES BETWEEN THE TWO ITEMS DO NOT PRESENT SIGNS OF SEIZING OR EXCESSIVE WEAR.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444712 TERMINAL CUP IMPACTOR FOR METAL BACK CC SURGICAL INSTRUMENT FOR HIP LXH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1