BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP PF FMRL HD RESURF 46MM

    MDR report key: 3936260 · Received July 15, 2014

    Report

    Report Number
    0001825034-2014-06183
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    August 24, 2009
    Report Date
    October 18, 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.

    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

    AS PART OF A RETROSPECTIVE CLINICAL STUDY, A PATIENT WAS IDENTIFIED WHO UNDERWENT RIGHT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2009. SUBSEQUENTLY, THE PATIENT EXPERIENCED UNSPECIFIED MEDICAL COMPLICATIONS, NOTED ON (B)(6) 2009. THERE HAS BEEN NO REPORTED REVISION PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A RIGHT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2009. DURING POST-OPERATIVE MONITORING, UNSPECIFIED MEDICAL COMPLICATIONS WERE NOTED ON (B)(6) 2009. 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. AN INVOICE HISTORY COULD NOT BE LOCATED TO CONFIRM THE SURGERY DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412288 RECAP PF FMRL HD RESURF 46MM PROSTHESIS, HIP KXA BIOMET ORTHOPEDICS N/A 874470

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R