BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHEAD RECON STEM IMPLANT NON-COATED, SIZE 4

    MDR report key: 5331617 · Received December 29, 2015

    Report

    Report Number
    0008031020-2015-00733
    Event Type
    Malfunction
    Date Received
    December 29, 2015
    Date of Event
    September 24, 2013
    Report Date
    September 26, 2013
    Manufacturer
    STRYKER GMBH
    Product Code
    KWI
    PMA / PMN Number
    K023604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE IS NOT AVAILABLE TO STRYKER.

    Description of Event or Problem · 1

    IMPLANT WAS LOOSE IN THE PACKAGING - POUCH BREACH - IMPLANT BREACH WAS OF THE HEAVIER STEMMED IMPLANTS - A QUALITY HOLD HAS BEEN PLACED ON PART NUMBERS 310-0007, 310-2017, 310-2025, RHA-S460, AND RCN-S460.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857163 RHEAD RECON STEM IMPLANT NON-COATED, SIZE 4 ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS KWI STRYKER GMBH 22846901

    Patients

    Seq Age Sex Outcome Treatment
    1 Other