BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP CEMENT FMRL HEAD RESUR46MM

    MDR report key: 3924444 · Received July 9, 2014

    Report

    Report Number
    0001825034-2014-05996
    Event Type
    Injury
    Date Received
    July 9, 2014
    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

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

    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 THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 8 STATES, ¿DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING.¿ THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05996 / -05997).

    Description of Event or Problem · 1

    AS PART OF A RETROSPECTIVE CLINICAL STUDY, A PATIENT WAS IDENTIFIED WHO UNDERWENT A RIGHT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2005 DUE TO OSTEOARTHRITIS. SUBSEQUENTLY, PATIENT EXPERIENCED TWO ANTERIOR DISLOCATIONS AND TWO POSTERIOR DISLOCATIONS, WHICH WERE TREATED BY CLOSED REDUCTIONS. NO REVISION PROCEDURE HAS BEEN REPORTED.

    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 DUE OSTEOARTHRITIS. SUBSEQUENTLY, PATIENT EXPERIENCED TWO ANTERIOR DISLOCATIONS AND TWO POSTERIOR DISLOCATIONS, WHICH WERE TREATED BY CLOSED REDUCTIONS. NO REVISION PROCEDURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401053 RECAP CEMENT FMRL HEAD RESUR46MM PROSTHESIS, HIP KXA BIOMET ORTHOPEDICS N/A 135160

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization