BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 3214107 · Received July 3, 2013

    Report

    Report Number
    1644408-2013-00356
    Event Type
    Other
    Date Received
    July 3, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 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 1.9 MONTHS OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THE HEALTHCARE PROFESSIONAL INDICATED A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. THERE IS 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 DISPOSED OF AT THE HOSPITAL AND NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED TWO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT: NCMR # 20901 INVOLVED THREE PARTS THAT WERE SCRAPPED FOR NONCONFORMING FEATURES AND NCMR # 20886 SHOWED A DOCUMENTATION ERROR WHICH WAS CORRECTED AND ALL OF THE PARTS WERE ACCEPTED. (B)(4). THE ROOT CAUSE FOR THE DISLOCATION WAS NOT DETERMINED WITH CONFIDENCE. SEVERAL FACTORS NOT RELATED TO THE IMPLANT CAN PLAY A ROLE IN DISLOCATION SUCH AS: LOOSE JOINT FROM INADEQUATE SOFT TISSUE AND PATIENT ACTIVITY. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    SECOND REVISION SURGERY - THE PT SUFFERED FROM A DISLOCATION OF HER ORIGINAL REVERSE. THE INSERT AND GLENOSPHERE WERE REMOVED AND THE PT WAS TRIALED WITH A 40 N GLENOSHERE AND 40 + 4 INSERT THAT WERE FOUND TO PROVIDE SUFFICIENT STABILITY. THESE IMPLANTS WERE THEN IMPLANTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303537 RSP SHOULDER GLENOID HEAD W/RETAINING SCREW/NEUTRAL KWS ENCORE MEDICAL, L.P. 869C1127

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention 508-01-036, LOT 860C1002