BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP PF FMRL HD RESURF 48MM

    MDR report key: 3943414 · Received July 18, 2014

    Report

    Report Number
    0001825034-2014-06277
    Event Type
    Injury
    Date Received
    July 18, 2014
    Report Date
    September 17, 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

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECT PRODUCT IDENTIFICATION.

    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. THIS FOLLOW UP MEDWATCH IS ALSO BEING SUBMITTED TO REPORT THAT IT IS A DUPLICATE OF MEDWATCH (B)(4), 1825034-2014-06227 AND 06228.

    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.

    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) 2011. DURING POST-OPERATIVE MONITORING, A PULMONARY EMBOLUS WAS NOTED ON (B)(6) 2011. 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. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE SURGERY DATE.

    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) 2011. DURING POST-OPERATIVE MONITORING, A TROCHANTERIC FRACTURE WAS NOTED ON (B)(6) 2011. A TROCHANTERIC CLIP WAS UTILIZED TO REPAIR THE FRACTURE. THESE FINDINGS WERE FOUND DUE TO FOLLOW UP MONITORING, THERE WERE NO SYMPTOMS REPORTED BY THE PATIENT.

    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) 2011. SUBSEQUENTLY, THE PATIENT EXPERIENCED A PULMONARY EMBOLUS NOTED ON (B)(6) 2011. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE SURGERY DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422963 RECAP PF FMRL HD RESURF 48MM PROSTHESIS, HIP KXA BIOMET ORTHOPEDICS N/A 653070

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R