BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP CEMENT FEMORAL HEAD RESUR 46M

    MDR report key: 3921606 · Received July 9, 2014

    Report

    Report Number
    0001825034-2014-06015
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    September 5, 2007
    Report Date
    October 18, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KXA
    PMA / PMN Number
    PK021799
    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 THESE TYPES OF EVENTS CAN OCCUR UNDER POSSIBLE ADVERSE EFFECTS: 14. INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE OF THE FEMORAL NECK AND/OR POSTOPERATIVE PAIN.

    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

    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 LEFT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2007. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2007 DUE TO FEMORAL NECK FRACTURE. A REVIEW OF INVOICE HISTORY CONFIRMS BOTH SURGERY DATES AND THAT THE FEMORAL RESURFACING HEAD WAS REMOVED AND REPLACED WITH A MODULAR HEAD, TAPER INSERT AND FEMORAL STEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT LEFT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2007. SUBSEQUENTLY, SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2007 DUE TO FEMORAL NECK FRACTURE. A REVIEW OF INVOICE HISTORY CONFIRMS BOTH SURGERY DATES AND THAT THE FEMORAL RESURFACING HEAD WAS REMOVED AND REPLACED WITH A MODULAR HEAD, TAPER INSERT AND FEMORAL STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399998 RECAP CEMENT FEMORAL HEAD RESUR 46M PROSTHESIS, HIP KXA BIOMET ORTHOPEDICS N/A 153930

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R