BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FMP HIP

    MDR report key: 4130001 · Received September 30, 2014

    Report

    Report Number
    1644408-2014-00593
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 17, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K974095
    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 TO REMOVE METAL ON METAL IMPLANTS AFTER 9.2 YEARS OF 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 NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED THIS IS THE FIRST COMPLAINT AGAINST LOT NUMBER 211672. (B)(4). THE EVENT IS DEEMED TO BE NON-PRODUCT RELATED AND THE RESULT OF THE PATIENT'S DECISION TO HAVE THE ORIGINAL METAL ON METAL IMPLANTS REMOVED. 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 PATIENT WANTING THE METAL-ON-METAL DEVICE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609119 FMP HIP FMP FLARED RIM SHELL, 3 SCREWHOLE CLUSTER 50MM LPH ENCORE MEDICAL, L.P. 211672

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention (B)(4), LOT 243482| (B)(4), LOT 891031| (B)(4), LOT 250682B| (B)(4), LOT 243592