BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP SHOULDER

    MDR report key: 3863889 · Received June 10, 2014

    Report

    Report Number
    1644408-2014-00354
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K092873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS THE PATIENT'S GLENOSPHERE DISASSOCIATED FROM THE BASEPLATE. THE HEALTHCARE PROFESSIONAL INDICATED 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 MADE AVAILABLE 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 SHOWED THERE ARE 7 PRIOR COMPLAINTS ON PART NUMBER 508-44-101, RSP GLENOID HEAD. (B)(4). THIS INVESTIGATION IS LIMITED IN SCOPE BECAUSE THE EXPLANTED PRODUCTS WERE NOT RETURNED TO DJO SURGICAL AND A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. FACTORS THAT COULD CONTRIBUTE TO A GLENOID HEAD DISASSOCIATION FROM A BASEPLATE INCLUDE TRAUMA AND EXCESSIVE LOADING OF THE SHOULDER PROSTHESIS SUCH AS CARRYING HEAVY WEIGHT, OR CARRYING A HEAVY EXTENDED LOAD, EXCESSIVE RANGE OF MOTION (ROM), AND IMPROPER TIGHTENING OF GLENOID HEAD RETAINING SCREW. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT.

    Description of Event or Problem · 1

    SECOND REVISION SURGERY - DUE TO THE PATIENT'S GLENOSPHERE DISASSOCIATING FROM THE BASEPLATE. THE SURGEON EXCHANGED THE HEAD AND LINER AND ADDED A REVERSE SHOULDER PROSTHESIS MONOBLOCK SPACER SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340823 RSP SHOULDER RSP GLENOID HEAD W/RETAINING SCREW / NEUTRAL 44MM KWS ENCORE MEDICAL, L.P. 877C1010

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention (B)(4), LOT 925F1000