BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 3122605 · Received May 15, 2013

    Report

    Report Number
    1644408-2013-00284
    Event Type
    Other
    Date Received
    May 15, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS IDENTIFIED AS DISLOCATION AFTER 1.5 MONTHS OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE HOSPITALIZATION - INITIAL OR PROLONGED. 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 BY THE HOSPITAL AND NOT RETURNED 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 SHOWS THIS IS THE (B)(4) COMPLAINT FOR THIS PART NUMBER: (B)(4) DUE TO DISLOCATION, (B)(4) FOR DISSOCIATION, (B)(4) DUE TO INFECTION, NINE FOR INSTABILITY, SIX DUE TO TRAUMA, THREE FOR NON-ASSEMBLY, TWO DUE TO PAIN, TWO FOR TAPER NON-ENGAGEMENT, ONE DUE TO A TIGHT JOINT/LIMITED RANGE OF MOTION, ONE PART WAS MALPOSITIONED, ONE DUE TO LOSS OF FIXATION, AND ONE CEMENT IMPINGEMENT. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE DISLOCATION WAS MOST LIKELY DUE TO THE PATIENT FALLING. THE INFORMATION REVIEWED SHOWED THAT THE PRODUCT MET ALL DESIGN, MATERIAL, AND MANUFACTURING SPECIFICATIONS. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - PT FELL AND DISLOCATED RIGHT SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214814 RSP SHOULDER HUMERAL SOCKET SHELL, NEUTRAL KWS ENCORE MEDICAL, L.P. 848C1261

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention (B)(4), LOT 855C1178