BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP

    MDR report key: 3915628 · Received July 7, 2014

    Report

    Report Number
    0001825034-2014-05966
    Event Type
    Injury
    Date Received
    July 7, 2014
    Date of Event
    January 3, 2012
    Report Date
    October 18, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KXA
    PMA / PMN Number
    PN/A
    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 ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH 1825034-2014-05966 ASSOCIATED WITH PATIENT (B)(6) IS A DUPLICATE OF MEDWATCH 1825034-2013-06227 ASSOCIATED WITH PATIENT (B)(6). THIS MEDWATCH 1825034-2014-05966 IS CONSIDERED CLOSED AT THIS TIME.

    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. PRODUCT IDENTIFICATION/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 REVISION PROCEDURE 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

    EVENT DESCRIPTION ¿ 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 A RIGHT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2006. SUBSEQUENTLY, PATIENT WAS REVISED TO A TOTAL HIP ON AN UNKNOWN DATE DUE TO INFLAMMATION, SOFT TISSUE MASS, AND LOW METAL ION LEVELS. A REVIEW OF INVOICE HISTORY COULD NOT CONFIRM THE INITIAL SURGERY DATE OR PROVIDE DETAILS ON WHEN THE REVISION SURGERY TOOK PLACE. ADDITIONAL INFORMATION RECEIVED REVEALED UNEXPLAINED INFLAMMATION, SOFT TISSUE MASS WITHOUT WEAR, AND METAL ION LEVELS LOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT RIGHT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2006. SUBSEQUENTLY, PATIENT WAS REVISED TO A TOTAL HIP ON AN UNKNOWN DATE DUE TO INFLAMMATION, SOFT TISSUE MASS, AND LOW METAL ION LEVELS. A REVIEW OF INVOICE HISTORY COULD NOT CONFIRM THE INITIAL SURGERY DATE OR PROVIDE DETAILS ON WHEN THE REVISION SURGERY TOOK PLACE.

    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) 2006. SUBSEQUENTLY, PATIENT WAS REVISED TO A TOTAL HIP ON AN UNKNOWN DATE DUE TO INFLAMMATION, SOFT TISSUE MASS, AND LOW METAL ION LEVELS. A REVIEW OF INVOICE HISTORY COULD NOT CONFIRM THE INITIAL SURGERY DATE OR PROVIDE DETAILS ON WHEN THE REVISION SURGERY TOOK PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393757 UNKNOWN HIP PROSTHESIS, HIP KXA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R