BEUDAMED
    FDA Adverse Event Other Summary report: N

    LINK MP RECONSTRRUCTION HIP SYSTEM - TRIAL STEM

    MDR report key: 3240781 · Received July 16, 2013

    Report

    Report Number
    9610548-2013-00004
    Event Type
    Other
    Date Received
    July 16, 2013
    Report Date
    July 16, 2013
    Manufacturer
    WALDEMAR LINK GMBH & CO. KG
    Product Code
    LZO
    PMA / PMN Number
    K955296
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAILURE WAS DETECTED FROM A LINK EMPLOYEE BY ORDERING A SAMPLE FROM STOCK. DURING THE INVESTIGATION WE IDENTIFIED THAT ONLY BATCHES FROM A SPECIFIC SUPPLIER WERE AFFECTED. ALL BATCHES WERE PRODUCED IN THE YEARS OF 2010 TO 2012. SO FAR WE REC'D NO COMPLAINTS OR INCIDENTS, WHICH MIGHT BE CONNECTED TO THE AFFECTED INSTRUMENTS. THE AFFECTED TRIAL STEMS WERE DISTRIBUTED TO THE FOLLOWING COUNTRIES: USA, (B)(4). THE REASON FOR THE RECALL ARE UNSPECIFIC DRAWINGS OF THE AFFECTED INSTRUMENTS, WHICH LEAD TO MISUNDERSTANDING AND MISINTERPRETATIONS. A CAPA WAS STARTED. THE CAPA PLAN COVERS BESIDE THE RECALL NEW TECHNICAL DRAWINGS AND A PROCESS REVIEW OF THE FINAL CHECK.

    Description of Event or Problem · 1

    A POTENTIAL HAZARD HAS BEEN IDENTIFIED IN THE APPLICATIONS OF THE MP TRIAL STEM. WALDEMAR LINK (B)(4) HAS DISCOVERED THAT THE AFFECTED INSTRUMENTS WERE PRODUCED WITH A WRONG DESIGN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330511 LINK MP RECONSTRRUCTION HIP SYSTEM - TRIAL STEM MP TRIAL STEM LZO WALDEMAR LINK GMBH & CO. KG SEE ATTACHMENT SEE ATTACHMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other