BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND METAGLENE

    MDR report key: 7014829 · Received November 9, 2017

    Report

    Report Number
    1818910-2017-28517
    Event Type
    Injury
    Date Received
    November 9, 2017
    Date of Event
    October 12, 2017
    Report Date
    October 12, 2017
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    HSD
    PMA / PMN Number
    K120174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # : (B)(4).

    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT DESCRIPTION REPORTS A REVISION DUE TO INFECTION. THE DEVICES ASSOCIATED TO THE COMPLAINT WERE RETURNED FOR ANALYSIS. THE DHR ANALYSIS PERFORMED FOR ALL AFFECTED PRODUCTS DID NOT REVEAL ANY ANOMALIES THAT COULD BE RELATED TO THE ISSUE REPORTED ON THE COMPLAINT. NO ANOMALY WAS DETECTED. ALL THE AFFECTED BATCHES WERE MANUFACTURED IN 2012. A SEARCH INTO THE COMPLAINTS DATABASE WAS PERFORMED, NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE AFFECTED PRODUCT CODE(S) AND LOT(S) COMBINATION(S). BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE INCIDENT COULD NOT BE DETERMINED. DEVICE HISTORY LOT: THE DHR ANALYSIS PERFORMED FOR PRODUCT CODE 130760000/ BATCH 5201464 DID NOT REVEAL ANY ANOMALIES THAT COULD BE RELATED TO THE ISSUE REPORTED ON THE COMPLAINT. (B)(4) PARTS WERE MANUFACTURED PER SPECIFICATION. BATCH 5201464 WAS MANUFACTURED IN DECEMBER 2012. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED TO ADDRESS INFECTION OF DELTA XTEND IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794381 DXTEND METAGLENE SHOULDER METAGLENE HSD DEPUY FRANCE SAS 3003895575 5201464

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention