BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP CEMENT FMRL HD RESUR 42M

    MDR report key: 3924443 · Received July 9, 2014

    Report

    Report Number
    0001825034-2014-05995
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 16, 2009
    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

    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 - UNKNOWN; MANUFACTURE DATE ¿ UNKNOWN. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A SURGICAL COMPLICATION OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY.

    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

    THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THESE TYPES OF EVENTS CAN OCCUR: ¿DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING.¿ THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05995 AND 1825034-2014-08053).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A RETROSPECTIVE CLINICAL STUDY UNDERWENT RIGHT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2006 DUE TO DYSPLASIA. SUBSEQUENTLY, PATIENT EXPERIENCED DISLOCATION, WHICH WAS TREATED BY CLOSED REDUCTION. ADDITIONAL INFORMATION RECEIVED REPORTS PATIENT WAS REVISED (B)(6) 2009 DUE TO UNKNOWN REASONS. THE CUP AND HEAD WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A (B)(4) STUDY UNDERWENT RIGHT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2006 DUE TO DYSPLASIA. SUBSEQUENTLY, PATIENT EXPERIENCED DISLOCATION, WHICH WAS TREATED BY CLOSED REDUCTION. NO REVISION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401972 RECAP CEMENT FMRL HD RESUR 42M PROSTHESIS, HIP KXA BIOMET ORTHOPEDICS N/A 472440

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R