BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2885334 · Received December 19, 2012

    Report

    Report Number
    1644408-2012-00661
    Event Type
    Other
    Date Received
    December 19, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    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 TO REMEDY PAIN AND LIMITED FUNCTION AFTER (B)(6) OF PATIENT USE. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE 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 NOT RETURNED 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 SHOWS THIS IS THE (B)(4) COMPLAINT FOR THIS PART NUMBER: (B)(4) DUE TO DISLOCATION, (B)(4) DUE TO TRAUMA, (B)(4) DUE TO INFECTION, (B)(4) FOR DISSOCIATION, (B)(4) DUE TO INSTABILITY, (B)(4) FOR PAIN, (B)(4) FOR NON-ASSEMBLY, (B)(4) BROKEN SCREW, AND (B)(4) FOR STABILITY/POOR JOINT ISSUES. THIS IS THE (B)(4) COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE PAIN AND LIMITED FUNCTION WAS NOT DETERMINED WITH CONFIDENCE. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT. 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 HAD PAIN AND NO FUNCTION. THE SURGEON REMOVED THE GLENOID HEAD AND IMPLANTED A REGULAR HUMERAL HEAD AND HEMISPHERICAL ADAPTER. THE SHELL AND LINER WERE ALSO REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER GLENOID HEAD W/RETAINING SCREW, NEUTRAL KWS ENCORE MEDICAL, L.P. 869C1072

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention (B)(4), LOT 852C1078| (B)(4), LOT 856C1030