BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP SHOULDER

    MDR report key: 3981091 · Received August 5, 2014

    Report

    Report Number
    1644408-2014-00502
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 31, 2014
    Report Date
    July 31, 2014
    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 FOR A LOOSE MONOBLOCK STEM. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS A 12 MINUTE 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 (B)(4) NON-CONFORMING MATERIAL REPORTS (NCMR'S) ASSOCIATED WITH THIS PRODUCT. NCMR'S # (B)(4) ASSOCIATED WITH THE GLENOID HEAD COMPONENT RELATED TO LEGIBILITY OF "NOTE 4" AND NON-CONFORMANCE OF DIMENSION "CIRCULARITY .0013", AFFECTED PARTS WERE REWORKED AND SCRAPED RESPECTIVELY. NONE OF THESE NCMR'S COULD CONTRIBUTE TO THIS EVENT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED (B)(4) PRIOR COMPLAINTS ON PART NUMBER 508-32-101, GLENOID HEAD, 32MM. OF THESE (B)(4) COMPLAINTS, (B)(4) COMPLAINTS WERE FOR DISLOCATION/DISASSOCIATION, (B)(4) COMPLAINTS FOR DEVICE LOOSENING/POOR JOINT/FIT ISSUE AND REST OF THE COMPLAINTS WERE FOR INFECTION, PAIN AND TRAUMA ISSUES. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. SEVERAL FACTORS THAT COULD CONTRIBUTE TO THIS EVENT INCLUDE, LOOSE JOINT FROM INADEQUATE SOFT TISSUE SUPPORT, AND EXCESSIVE RANGE OF MOTION (ROM), IMPLANTS POSITIONING, AND HIGH PATIENT ACTIVITY LEVEL (HEAVY LIFTING OR EXCESSIVE LOADING OF THE SHOULDER PROSTHESIS). THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO A LOOSE MONOBLOCK STEM THE SURGEON PERFORMED A REPRESS FIT OF THE JOINT. HE CHANGED OUT THE STEM AND THE 32 GLENOSPHERE AND REPLACED IT WITH A 36.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO A LOOSE MONOBLOCK STEM, THE SURGEON PERFORMED A REPRESS FIT OF THE JOINT. HE CHANGED OUT THE STEM AND THE 32 GLENOSPHERE AND REPLACED IT WITH A 38.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456313 RSP SHOULDER RSP GLENOID HEAD W/RETAINING SCREW / NEUTRAL 32MM KWS ENCORE MEDICAL, L.P. 862C1401

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention 508-01-432,LOT 860C1007