BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP SHOULDER

    MDR report key: 3902972 · Received June 30, 2014

    Report

    Report Number
    1644408-2014-00405
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS IDENTIFIED AS THE DEVICE LOOSENING AFTER 1.8 YEARS OF PATIENT USE. THE HEALTHCARE PROFESSIONAL INDICATED A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. HOSPITALIZATION - INITIAL OR PROLONGED WAS REQUIRED. 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 FROM THIS LOT. THE ROOT CAUSE FOR THE DEVICE LOOSENING WAS REPORTED AS A FALL. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO LOOSE GLENOID IMPLANTS THAT RESULTED FROM THE PATIENT FALLING; THE IMPLANTS DID NOT FAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379527 RSP SHOULDER RSP HYDROXYAPATITE-COATED GLENOID BASEPLATE 6.5 X 30MM KWS ENCORE MEDICAL, L.P. 866C1329

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| O| R (B)(4), LOT 832C1059| (B)(4), LOT 832C1059| (B)(4), LOT 831C1081| (B)(4), LOT 832C1049| (B)(4), LOT 862C1162