BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP CEMENT FMRL HD RESUR52MM

    MDR report key: 3924403 · Received July 9, 2014

    Report

    Report Number
    0001825034-2014-06016
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    August 8, 2005
    Report Date
    September 17, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KXA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 RELATED TO THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN."

    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) 2005. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2005 DUE TO FEMORAL NECK FRACTURE.

    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) 2005. SUBSEQUENTLY, THE PATIENT EXPERIENCED A FEMORAL NECK FRACTURE AND WAS REVISED ON (B)(6) 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401006 RECAP CEMENT FMRL HD RESUR52MM PROSTHESIS, HIP KXA BIOMET ORTHOPEDICS N/A 252960

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R