BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP SHOULDER

    MDR report key: 3963868 · Received July 29, 2014

    Report

    Report Number
    1644408-2014-00486
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS THAT THE GLENOID HEAD AND CENTRAL SCREW WERE DISASSOCIATED FROM THE BASEPLATE. 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 RETURNED TO DJO SURGICAL ON 12 AUGUST 2014 FOR EXAMINATION. THREE EXPLANTED PRODUCTS WERE RETURNED TO DJO FOR INSPECTION: THE RSP GLENOID HEAD (PART NUMBER 508-36-101, LOT 869C1171), THE RSP GLENOID HEAD RETAINING SCREW (508-00-001, LOT 850C1109), AND ONE OF THE FOUR RSP 5.0 MM LOCKING SCREWS, 26 MM, (506-03-126, LOT 834C1123). THE LOT OF THE ASSOCIATED RSP BASEPLATE (508-32-104) AND OTHER THREE LOCKING SCREWS WERE NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THESE PRODUCTS. (B)(4). THE ROOT CAUSE FOR THE GLENOID HEAD AND CENTRAL SCREW DISASSOCIATING FROM THE BASEPLATE WAS NOT REPORTED AND COULD NOT BE DETERMINED WITH CONFIDENCE. FACTORS THAT CAN CONTRIBUTE TO A GLENOID HEAD DISASSOCIATION FROM A BASEPLATE INCLUDE TRAUMA AND EXCESSIVE LOADING OF THE SHOULDER PROSTHESIS SUCH AS CARRYING A HEAVY WEIGHT, OR CARRYING A HEAVY EXTENDED LOAD, IMPROPER TIGHTENING OF GLENOID HEAD RETAINING SCREW, A LOCKING SCREW SITTING TOO PROUD ABOVE THE BASEPLATE, OR PRESENCE OF SOFT TISSUE OR DEBRIS ON MORSE TAPER COULD CAUSE IMPROPER FIXATION OF THE GLENOID HEAD. IT CANNOT BE DETERMINED IF THE LOCKING SCREW WAS SITTING PROUD FROM THE INITIAL INSTALLATION, OR IF THE PATIENT HAD A SIGNIFICANT SHOULDER LOAD THAT PULLED THE FACE OF THE RSP BASEPLATE, AND ONE OF THE LOCKING SCREWS, AWAY FROM THE GLENOID BONE. 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 INTERMITTENT PAIN ASSOCIATED WITH WHAT THE PATIENT DESCRIBED AS A SNAPPING SOUND. AFTER SEVERAL X-RAYS LOOKED FINE, ONE WAS TAKEN IN (B)(6) SHOWING THE GLENOID HEAD AND CENTRAL SCREW HAD DISASSOCIATED FROM THE BASEPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441274 RSP SHOULDER RSP GLENOID HEAD W/RETAINING SCREW / NEUTRAL 36MM KWS ENCORE MEDICAL, L.P. 869C1171

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other| R