BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2945069 · Received January 31, 2013

    Report

    Report Number
    1644408-2013-00052
    Event Type
    Other
    Date Received
    January 31, 2013
    Date of Event
    January 24, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS DUE TO DISSOCIATION OF THE SHELL AND STEM. THERE WAS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE REVISION SURGERY. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. THE ROOT CAUSE FOR THE DISSOCIATION CANNOT BE DETERMINED WITH CONFIDENCE. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE SHELL AND STEM DISSOCIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43655 RSP SHOULDER HUMERAL SOCKET SHELL, +8MM OFFSET KWS ENCORE MEDICAL, L.P. 854C1053

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention (B)(4), LOT 918F1013