BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP SHOULDER

    MDR report key: 3812328 · Received May 15, 2014

    Report

    Report Number
    1644408-2014-00296
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS INSTABILITY AFTER 7.8 YEARS OF PATIENT USE. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED THIS IS THE FIRST COMPLAINT FOR A PART FROM THIS LOT. THE ROOT CAUSE FOR THE INSTABILITY WAS REPORTED AS A POSSIBLE BONE DISEASE. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT'S GLENOID BONE WAS HOLLOW AND THE BASEPLATE WAS FLOATING ON THE STEM. THE SURGEON ORIGINALLY THOUGHT THE PATIENT HAD AN INFECTION IN THE JOINT BUT THE TESTING WAS NEGATIVE FOR INFECTION. POSSIBLE BONE DISEASE PRESENT. THE SURGEON REVISED THE JOINT TO A HEMI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291949 RSP SHOULDER RSP HUMERAL SOCKET SHELL, NEUTRAL KWS ENCORE MEDICAL, L.P. 53771380

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention 508-32-003, LOT 267732