BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP SHOULDER

    MDR report key: 3841388 · Received May 30, 2014

    Report

    Report Number
    1644408-2014-00328
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS DISLOCATION/DISASSOCIATION AFTER 4.3 MONTHS 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. 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 FOURTH COMPLAINT FOR THIS PART NUMBER FROM THIS LOT. THE ROOT CAUSE FOR THE DISLOCATION WAS REPORTED AS A FALL; THE PATIENT WAS REPORTED TO HAVE AN UNSTABLE WALKING GATE. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT.

    Description of Event or Problem · 1

    REVISION SURGERY - PATIENT'S SHOULDER DISLOCATED DUE TO A FALL. NOT A PRODUCT FAULT PER THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318188 RSP SHOULDER RSP GLENOID HEAD W/RETAINING SCREW / NEUTRAL 32MM KWS ENCORE MEDICAL, L.P. 862C1305

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other| R 508-00-032, LOT 855C1245