BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 3254163 · Received July 25, 2013

    Report

    Report Number
    1644408-2013-00386
    Event Type
    Other
    Date Received
    July 25, 2013
    Date of Event
    July 12, 2013
    Report Date
    July 12, 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 1.1 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 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 (B)(4) SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED ONE NON-CONFORMING MATERIAL REPORT ASSOCIATE WITH THIS PRODUCT: (B)(4) INVOLVED ONE PART THAT WAS RETURNED TO THE VENDOR FOR INCORRECT LASER MARKING. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE 117TH COMPLAINT FOR THIS PRODUCT: ONE FOR A DAMAGED LOCKING MECHANISM, THREE FOR DIMENSIONAL CONCERN, TWO REVISIONS, 14 DUE TO DISSOCIATION, 58 DUE TO DISLOCATION, TWO DUE TO PAIN, 11 DUE TO INFECTION, 12 DUE TO TRAUMA, ONE FOR DEVICE LOOSENING, 13 FOR STABILITY/POOR JOINT ISSUES, AND ONE FOR MALPOSITION. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE DISLOCATION WAS MOST LIKELY DUE TO THE PATIENT'S SHOULDER BEING PULLED WHILE BEING ASSISTED UP FROM A CHAIR. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT HAD JUST BEEN IN FOR HER 6 WEEK FOLLOW UP AND EVERYTHING WAS FINE. SHE CALLED LAST WEEK SAYING SHE FELT A CLICKING IN HER SHOULDER. UPON FURTHER QUESTIONING, THE PT HAD SOMEONE HELP HER UP FROM A CHAIR AND THEY PULLED ON HER SHOULDER CAUSING IT TO DISLOCATE. THE SHOULDER WAS CLOSED-REDUCED BUT IT WAS DETERMINED TO BE UNSTABLE AT THIS POINT. THE SURGEON REMOVED THE SHELL AND INSERT AND REPLACED THEM WITH A +8 SHELL AND A SEMICONSTRAINED LINER. THIS WAS DETERMINED TO BE SUFFICIENTLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347648 RSP SHOULDER HUMERAL SOCKET SHELL, NEUTRAL KWS ENCORE MEDICAL, L.P. 848C1336

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention 508-01-032, LOT 859C1007