BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HA MLRY-HD POR LAT FMRL 11MM

    MDR report key: 3941209 · Received July 17, 2014

    Report

    Report Number
    0001825034-2014-06254
    Event Type
    Injury
    Date Received
    July 17, 2014
    Report Date
    October 18, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KXA
    PMA / PMN Number
    PK021403
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CORRECTED DATA: EVENT DESCRIPTION ¿ PATIENT WAS NOT ENROLLED IN A CLINICAL STUDY. A RETROSPECTIVE CLINICAL REVIEW IDENTIFIED THE PATIENT¿S EVENT.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN. PMA/510(K) NUMBER. MANUFACTURE DATE ¿ UNKNOWN.

    Description of Event or Problem · 1

    AS PART OF A RETROSPECTIVE CLINICAL STUDY, A PATIENT WAS IDENTIFIED WHO UNDERWENT A TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2006. DURING POST-OPERATIVE MONITORING, A PERIPROSTHETIC FEMORAL FRACTURE WAS NOTED ON FEB(B)(6) 2006. 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 TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2006. DURING POST-OPERATIVE MONITORING, A PERIPROSTHETIC FEMORAL FRACTURE WAS NOTED ON (B)(6) 2006. THESE FINDINGS WERE FOUND DUE TO FOLLOW UP MONITORING, THERE WERE NO SYMPTOMS REPORTED BY THE PATIENT. THE FEMORAL COMPONENT SUBSIDED 1.5 CM AND BECAME SOLIDLY INGROWN. THERE HAS BEEN NO 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) 2006. DURING POST-OPERATIVE MONITORING, A PERIPROSTHETIC FEMORAL FRACTURE WAS NOTED ON (B)(6) 2006. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419500 HA MLRY-HD POR LAT FMRL 11MM PROSTHESIS, HIP KXA BIOMET ORTHOPEDICS N/A 688450

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention