BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALFA HIP

    MDR report key: 3891613 · Received June 24, 2014

    Report

    Report Number
    1644408-2014-00385
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K032729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS DUE TO A DISLOCATION AFTER 3.4 YEARS OF IMPLANT USE. 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. 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 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 REPORT (NCMR) ASSOCIATED WITH THIS PRODUCT. NCMR (B)(4) SHOWED (B)(4) PARTS (PART NUMBER: 410-35-112) SCRAPPED AND (B)(4) PARTS REWORKED DUE TO TOOL MARKS ON THE NECK. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED THIS IS THE FIRST COMPLAINT FOR A PART FROM THIS LOT. THE ROOT CAUSE OF THE DISLOCATION WAS REPORTED AS A NEED FOR A DIFFERENT SIZED OFFSET NECK. 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 THE HEAD DISLOCATING FROM THE CUP. THE SURGEON CHANGED OUT THE MODULAR NECK AND HEAD TO A DIFFERENT OFFSET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369219 ALFA HIP MOD FEMORAL NECK 12 DEGREE 12/14 CERASIVE TAPER LPH ENCORE MEDICAL, L.P. 54050141

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention (B)(4), LOT 53983270