BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2931665 · Received January 24, 2013

    Report

    Report Number
    1644408-2013-00029
    Event Type
    Other
    Date Received
    January 24, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL REVERSE SHOULDER PROSTHESIS (RSP) SURGERY WAS PERFORMED ON (B)(6) 2010 AND THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2013. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE NON-SERIOUS. 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 FOR THE RSP BASEPLATE AND GLENOID HEAD. THERE WERE TWO NON-CONFORMING MATERIAL REPORTS FOR THE SOCKET SHELL, NEITHER CONTRIBUTED TO THIS COMPLAINT. ONE INVOLVED A NONCONFORMANCE AND WAS SCRAPPED FOR SURFACE FINISH, THE OTHER INVOLVED 12 ITEMS BEING RETURNED TO VENDOR DUE TO DIMENSIONAL AND TAPER NONCONFORMANCE'S. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THERE ARE (B)(4) PRIOR COMPLAINTS DUE TO CENTRAL SCREW FRACTURES. THERE WERE NO DESIGN, MANUFACTURING, OR MATERIAL DEFECTS IDENTIFIED FROM THOSE COMPLAINT REPORTS. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS. THE ROOT CAUSE FOR THIS PRODUCT COMPLAINT WAS A FRACTURE OF A RSP GLENOID BASEPLATE CENTRAL 6.5 MM SCREW AFTER 2.2 YEARS OF PATIENT USE. THE DETAILS OF THE PATIENT BACKGROUND PRIOR TO THE FAILURE WERE NOT PROVIDED, AND THE EXPLANTED DEVICES WERE NOT RETURNED FOR EXAMINATION. HISTORICALLY, SUCH FAILURES AFTER A FEW YEARS OF USE ARE USUALLY THE RESULT OF FACTORS SUCH AS: A WEAKENED OR INADEQUATE VOLUME OF BONE STRUCTURE, LACK OF BONE IN-GROWTH INTO THE POROUS COAT, INADEQUATE SOFT TISSUE SUPPORT, LARGE OR FREQUENT SHOULDER TORQUES OR LOADS, TRAUMA, INFECTION, OR OTHER MEDICAL FACTORS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE BASEPLATE CENTER SCREW BROKE. THE SURGEON REMOVED THE BASEPLATE AND GLENOSPHERE AND REPLACED THEM WITH A HEMISPHERICAL SHOULDER. THE AGENT INDICATED THE SURGEON HAD THE SAME ISSUE WITH PREVIOUS CASES AND IS NO LONGER PERFORMING SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34248 RSP SHOULDER HYDROXYAPATITE-COATED GLENOID BASEPLATE KWS ENCORE MEDICAL, L.P. 866C1032

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention 508-00-000, LOT 855C1010| 508-32-101, LOT 862C1019| 508-00-032, LOT 848C1038