BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP SHOULDER

    MDR report key: 3810058 · Received May 14, 2014

    Report

    Report Number
    1644408-2014-00291
    Event Type
    Injury
    Date Received
    May 14, 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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS INSTABILITY AFTER AN UNKNOWN AMOUNT OF TIME IN VIVO; ORIGINAL SURGERY DATE NOT SUPPLIED OR LOCATED. 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. 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 INSTABILITY WAS REPORTED AS IMPINGEMENT CAUSED BY A BONE SPUR. 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 IMPINGEMENT; A BONE SPUR WAS FOUND ON THE GLENOSPHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288618 RSP SHOULDER RSP STANDARD HUMERAL SOCKET INSERT, 32MM KWS ENCORE MEDICAL, L.P. 53830186

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other| R