BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP PF FMRL HD RESURF 52MM

    MDR report key: 3940659 · Received July 17, 2014

    Report

    Report Number
    0001825034-2014-06240
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    December 4, 2008
    Report Date
    June 20, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KXA
    PMA / PMN Number
    PK023188
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY."

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: EVENT DESCRIPTION ¿ PATIENT WAS NOT ENROLLED IN A CLINICAL STUDY. A RETROSPECTIVE CLINICAL REVIEW IDENTIFIED THE PATIENT¿S EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A LEFT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2007. DURING POST-OPERATIVE MONITORING, A LOOSE FEMORAL COMPONENT WAS NOTED ON (B)(6) 2008. THESE FINDINGS WERE FOUND DUE TO FOLLOW UP MONITORING, THERE WERE NO SYMPTOMS REPORTED BY THE PATIENT. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE.

    Description of Event or Problem · 1

    AS PART OF A RETROSPECTIVE CLINICAL STUDY, A PATIENT WAS IDENTIFIED WHO UNDERWENT A LEFT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2007. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2008 DUE TO A LOOSE FEMORAL COMPONENT. THE FEMORAL COMPONENT WAS REMOVED AND REPLACED.

    Description of Event or Problem · 1

    AS PART OF A RETROSPECTIVE CLINICAL STUDY, A PATIENT WAS IDENTIFIED WHO UNDERWENT A LEFT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2007. DURING POST-OPERATIVE MONITORING, A LOOSE FEMORAL COMPONENT WAS NOTED ON (B)(6) 2008. THESE FINDINGS WERE FOUND DUE TO FOLLOW UP MONITORING. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418537 RECAP PF FMRL HD RESURF 52MM PROSTHESIS, HIP KXA BIOMET ORTHOPEDICS N/A 793150

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention