BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND GLENOSPHERE STD D42MM

    MDR report key: 4867755 · Received June 25, 2015

    Report

    Report Number
    1818910-2015-24338
    Event Type
    Injury
    Date Received
    June 25, 2015
    Date of Event
    June 18, 2015
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    KWS
    PMA / PMN Number
    PK120174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE (GLENOSPHERE) ASSOCIATED TO THE COMPLAINT WAS RETURNED FOR ANALYSIS. THE DHR ANALYSIS PERFORMED DID NOT REVEAL ANY ANOMALIES THAT COULD BE RELATED TO THE ISSUE REPORTED ON THE COMPLAINT. A SEARCH INTO THE COMPLAINTS DATABASE WAS PERFORMED, NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE AFFECTED LOT 5230087. BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    REASON FOR REVISION WAS IMPLANT BREAKAGE. ON X-RAY IT WAS FOUND THAT THE SCREW OF THE GLENOSPHERE HAD BROKEN AND THE GLENOSPHERE WAS DISENGAGED FROM THE METAGLENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411742 DXTEND GLENOSPHERE STD D42MM SHOULDER HEAD/GLENOSPHERE KWS DEPUY FRANCE SAS 3003895575 5230087

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention