BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP SHOULDER

    MDR report key: 5101381 · Received September 24, 2015

    Report

    Report Number
    1644408-2015-00561
    Event Type
    Injury
    Date Received
    September 24, 2015
    Date of Event
    September 2, 2015
    Report Date
    September 2, 2015
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    UDI-DI
    00888912024730
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS SHOULDER PAIN AND JOINT INSTABILITY AFTER 5.5 MONTHS OF PATIENT USE. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, OR ACCIDENTS THAT MAY HAVE CONTRIBUTED TO THE NEED FOR THIS REVISION SURGERY. THE HEALTHCARE PROFESSIONAL INDICATED 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. (B)(4). NO INFORMATION WAS PROVIDED THAT DEFINITIVELY DESCRIBED THE ROOT CAUSE OR REASON OF THE JOINT PAIN AND INSTABILITY. FACTORS THAT MAY CONTRIBUTE TO INSTABILITY AND PAIN NOT ASSOCIATED WITH THE IMPLANT ARE: IMPROPER IMPLANT SELECTION, DEGENERATIVE BONE DISEASE, AND IMPROPER SURGICAL TECHNIQUE. 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 THE PATIENT HAVING PAIN AND INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631980 RSP SHOULDER GLENOID, HEAD W/RETAINING SCREW, RSP, 32MM/NEUTRAL KWS ENCORE MEDICAL, L.P. 862C1916 00888912024730

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention