BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HP MBT CEM KEEL PUNCH SZ 4-7

    MDR report key: 4122720 · Received September 26, 2014

    Report

    Report Number
    1818910-2014-28898
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    July 3, 2012
    Report Date
    July 3, 2012
    Manufacturer
    1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE FOUND ADDITIONAL REPORTS OF BREAKAGE AGAINST THE REPORTED PRODUCT CODE. CAPA (B)(4) WAS PREVIOUSLY INITIATED TO INVESTIGATE, IDENTIFY ROOT CAUSE AND CORRECTIVE ACTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE CURRENT REPORTED EVENT BASED ON THE LACK OF THE PRODUCT TO EXAMINE. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    SMALL LIP ON THE ATTACHMENT SITE BROKE OFF DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601581 HP MBT CEM KEEL PUNCH SZ 4-7 KNEE INSTRUMENT/TRIAL LXH 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1