BEUDAMED
    FDA Adverse Event Summary report: N

    RSP SHOULDER

    MDR report key: 3063038 · Received April 17, 2013

    Report

    Report Number
    1644408-2013-00216
    Date Received
    April 17, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K041066
    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 REPORTED AS A FRACTURE AT THE PROXIMAL END OF THE HUMERUS DURING SURGERY AFTER 21 DAYS OF PATIENT USE. 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 AND NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED ONE NON-CONFORMING MATERIAL REPORT ASSOCIATED WITH THIS PRODUCT: THE PARTS WERE RETURNED TO THE VENDOR FOR OVERSIZED FEATURES. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE 35TH COMPLAINT FOR THIS PART NUMBER: TWO DUE TO DISLOCATION, ONE DUE TO DISSOCIATION, FIVE DUE TO INFECTION, FIVE FOR INSTABILITY, TEN DUE TO TRAUMA, ONE DUE TO PAIN, TWO REVISION SURGERIES, ONE MALPOSITION, FIVE FOR DEVICE LOOSENING, ONE DEVICE WAS CRACKED/BROKEN, ONE DUE TO SURGICAL TECHNIQUE, AND ONE FOR A PACKAGING ISSUE. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE FRACTURE WAS NOT DETERMINED WITH CONFIDENCE. IT WAS REPORTED THE PATIENT HAD SUFFERED FROM A MALUNION IN THE PAST. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT FRACTURED HER PROXIMAL HUMERUS WHILE REDUCING THE HUMERUS. THE PATIENT PREVIOUSLY HAD A MAL-UNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166140 RSP SHOULDER PRIMARY HUMERAL STEM KWS ENCORE MEDICAL, L.P. 810C1017

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention 415-00-100, LOT 7711161-10