BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FMP HIP

    MDR report key: 4862453 · Received June 23, 2015

    Report

    Report Number
    1644408-2015-00373
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    June 8, 2015
    Report Date
    June 8, 2015
    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 FOR INSTABILITY AND PAIN. THE LENGTH OF IN VIVO SERVICE WAS 3 YEARS. 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 THE MAIN CONTRIBUTOR COMPONENT LISTED IN THE COMPLAINT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED THERE HAVE BEEN 5 PRIOR COMPLAINTS REPORTED AGAINST THIS PART NUMBER; SUMMARY OF INVESTIGATIONS: 2 FOR DISLOCATION, 1 FOR TRAUMA, 1 FOR LOOSENESS, 1 UN-SPECIFIED SURGICAL REASON. THIS IS THE FIRST COMPLAINT AGAINST THIS LOT NUMBER. THE SURGEON REPORTED NO ISSUES ASSOCIATED WITH THE EXPLANTED PRODUCT AND PROVIDED NO INFORMATION THAT DEFINITIVELY DESCRIBED THE ROOT CAUSE OR REASON OF THE JOINT PAIN AND INSTABILITY. NO OTHER CONDITIONS RELATING TO THIS EVENT COULD BE DETERMINED WITH CONFIDENCE. FACTORS THAT MAY CONTRIBUTE TO JOINT PAIN AND INSTABILITY NOT ASSOCIATED WITH THE IMPLANT ARE: IMPROPER IMPLANT SELECTION, DEGENERATIVE BONE DISEASE, PATIENT NON-COMPLIANCE WITH MEDICAL INSTRUCTIONS. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    SECOND REVISION SURGERY - UNKNOWN REASON. PLEASE REFER TO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406296 FMP HIP SHELL, ACETABULAR, FLARED FMP W/HOLES SIZE58 LPH ENCORE MEDICAL, L.P. A1000001

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention 411-00-350,LOT 931B1021| 497-40-000,LOT 641C1020| 010-55-040,LOT 010A1029