BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND METAGLENE

    MDR report key: 5209417 · Received November 7, 2015

    Report

    Report Number
    1818910-2015-34637
    Event Type
    Injury
    Date Received
    November 7, 2015
    Date of Event
    October 20, 2015
    Report Date
    October 20, 2015
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    HSD
    PMA / PMN Number
    PK062250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DXTEND METAGLENE (PRODUCT CODE 130760000, LOT NUMBER 5240531) WAS NOT RETURNED FOR EVALUATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES ON THE PROVIDED PRODUCT AND LOT COMBINATION. IT IS UNCLEAR WHAT CAUSED THE DISASSOCIATION (IT IS PRESUMED THAT THE GLENOSPHERE DISASSOCIATED FROM THE METAGLENE). THE GLENOSPHERE SCREW IS HEAVILY DAMAGED BUT IT IS NOT CLEAR IF THIS IS CAUSE OR EFFECT OF THE DISASSOCIATION. IT IS ALSO UNCLEAR IF THE THREADED INSERT CAME LOOSE IN VIVO, OR IF IT WAS REMOVED IN ORDER TO EXAMINE THE CAPTURED GLENOSPHERE SCREW. WITHOUT FURTHER INFORMATION, NO CONCLUSIONS CAN BE REACHED. NO FURTHER ACTION NEEDED. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS DISASSOCIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739597 DXTEND METAGLENE SHOULDER METAGLENE HSD DEPUY FRANCE SAS 3003895575 5240531

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention