BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP SHOULDER

    MDR report key: 3961395 · Received July 28, 2014

    Report

    Report Number
    1644408-2014-00480
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION WAS DETERMINED TO BE LOOSENESS AS WELL AS MIGRATION OF THE GLENOID BASEPLATE AND THE REQUIREMENT OF A REVISION SURGERY TO CORRECT THE CONDITION AFTER 11.6 MONTHS OF PATIENT USE. NO INFORMATION WAS REPORTED WITH THIS COMPLAINT ABOUT ANY OTHER PATIENT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE NEED FOR THIS 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 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 THIS IS THIS FIRST COMPLAINT AGAINST LOT NUMBER 866C1600. THERE HAVE BEEN (B)(4) PRODUCT COMPLAINTS AGAINST THIS PRODUCT. THIS IS THE (B)(4) COMPLAINT FOR DEVICE LOOSENESS AGAINST THIS PART NUMBER BUT NONE HAVE BEEN THE RESULT OF PRODUCT ISSUES. THE ROOT CAUSE FOR THIS PRODUCT COMPLAINT IS ATTRIBUTED TO LOOSENESS OF THE BASEPLATE THAT MIGRATED ALONG WITH THE GLENOID. THE EVENT IS NOT CONSIDERED A PRODUCT CAUSED EVENT. NO OTHER CONDITIONS RELATING TO THIS EVENT COULD BE DETERMINED WITH CONFIDENCE. SEVERAL FACTORS UNRELATED TO THE IMPLANT CAN PLAY A ROLE IN THE IMPLANT BECOMING LOOSE; SUCH AS LOOSE JOINT FROM DEGENERATIVE TISSUE AND IMPROPER IMPLANT SELECTION. THERE IS NO REPORTED INFORMATION THAT INDICATES A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THIS PRODUCT.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO THE BASEPLATE LOOSENING AND MOVING ALONG WITH THE GLENOSPHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437388 RSP SHOULDER RSP HYDROXYAPATITE-COATED GLENOID BASEPLATE 6.5 X 30MM KWS ENCORE MEDICAL, L.P. 866C1600

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention (B)(4), LOT 833C1085| (B)(4), LOT 832C1094| (B)(4), LOT 191H1019| (B)(4), LOT 831C1134| (B)(4), LOT 864C1282| (B)(4), LOT 832C1098