BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP SHOULDER

    MDR report key: 6201596 · Received December 22, 2016

    Report

    Report Number
    1644408-2016-01035
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    December 2, 2016
    Report Date
    February 14, 2017
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    UDI-DI
    00888912144223
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER NARRATIVE: THE REASON FOR THIS REVISION SURGERY WAS INSTABILITY. THE IN-VIVO LENGTH OF PATIENT SERVICE FOR THE IMPLANT WAS 1.2 YEARS. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, OR ACCIDENTS THAT MAY HAVE CONTRIBUTED TO THE NEED FOR THIS REVISION SURGERY. THERE ARE NO REPORTED PRE-EXISTING PATIENT HEALTH CONDITIONS. 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 NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) REVEALED NO DISCREPANCIES OR ISSUES WITH THE MANUFACTURING OF THIS PART. ALL CRITICAL DIMENSIONS AND SPECIFICATIONS IN EFFECT AT THE TIME THE PART WAS MANUFACTURED WERE MET. THE PRODUCT COMPLAINT REPORT HISTORY WAS REVIEWED AND NO TRENDS OR ON-GOING ISSUES WERE DEEMED AS PRESENT OR IN NEED OF REVIEW. THIS EVENT IS DEEMED TO BE NON-PRODUCT RELATED. THE ROOT CAUSE FOR THE INSTABILITY WAS NOT REPORTED. THE SCOPE OF THIS INVESTIGATION IS LIMITED WITHOUT HAVING THE PARTS AVAILABLE TO DJO SURGICAL FOR EVALUATION. OTHER CONDITIONS RELATING TO THIS EVENT COULD NOT BE DETERMINED WITH CONFIDENCE. INVENTORY CONTAINMENT IS NOT REQUIRED AS 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'S ORIGINAL SURGERY (B)(4) TOOK PLACE ON (B)(6) 2014. ANOTHER (B)(4) TOOK PLACE ON (B)(6) 2014. ANOTHER REVISION (B)(4) TOOK PLACE ON (B)(6) 2015. THE LAST SURGERY TOOK PLACE ON (B)(6) 2016. ALL REVISIONS TOOK PLACE BECAUSE THE PATIENT WAS UNSTABLE AND THE SURGEON KEPT INCREASING THE GLENOID SIZE IN ORDER TO TRY TO MAKE THE JOINT STABLE. HE WAS UNSUCCESSFUL, THUS REMOVING ALL (B)(4) IMPLANTS, ACCORDING TO THE REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851616 RSP SHOULDER BASEPLATE, GLENOID HA-COAT, RSP, 6.5MM X 30MM KWS ENCORE MEDICAL, L.P. 866C1904 00888912144223

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention 415-00-100,LOT 7714231| 506-00-008,LOT 814C1208| 506-03-114,LOT 831C1215| 506-03-130,LOT 835C1202| 508-00-008,LOT 854C1900| 508-32-104,LOT 866C1904| 508-40-101,LOT 875C1102