BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD METAGLENE V3.2

    MDR report key: 1358238 · Received April 2, 2009

    Report

    Report Number
    1818910-2009-01323
    Event Type
    Injury
    Date Received
    April 2, 2009
    Date of Event
    March 3, 2009
    Report Date
    March 3, 2009
    Manufacturer
    DEPUY FRANCE S.A.
    Product Code
    KWS
    PMA / PMN Number
    K021478
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE SAMPLE WAS NOT RETURNED, PROVIDED PHOTOGRAPHS CONFIRMED THE WEAR/NOTCHING. DEPUY FRANCE REVIEWED THE DEVICE HISTORY RECORDS AND FOUND THE PRODUCTS INITIALLY CONFORMED TO THE SPECIFICATIONS. PREVIOUS INVESTIGATIONS FOUND THE NATURE OF THE DESIGN (REVERSE SHOULDER), POSITIONING OF THE IMPLANT, AND THE PATIENT'S ANATOMY ARE ALL POSSIBLE CONTRIBUTING FACTORS. DEPUY FRANCE STATES THE DELTA XTEND DESIGN WILL CONTAIN ECCENTRIC GLENOSPHERE COMPONENTS THAT WILL MINIMIZE THE NOTCHING PROBLEM THAT LEADS TO POLY WEAR. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD THE PRODUCTS AND/OR ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS POLY WEAR/NOTCHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD METAGLENE V3.2 87KWS KWS DEPUY FRANCE S.A. NA 2297102

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention