BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP CEMENT FMRL HD RESUR 44M

    MDR report key: 3924393 · Received July 9, 2014

    Report

    Report Number
    0001825034-2014-05994
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    October 21, 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

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH AND TO CORRECT INFORMATION THAT WAS REPORTED IN ERROR ON THE INITIAL REPORT. CORRECT PRODUCT CODE IS KXA 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, MALALIGNMENT, MALPOSITION, EXCESSIVE, UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY, TRAUMA, WEIGHT GAIN, OR OBESITY. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS.¿ THIS REPORT IS NUMBER 1 OF 2 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2014- 05994 & 08428).

    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. MFR DATE - UNK. 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

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL/CORRECTED INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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 LEFT FEMORAL RESURFACING ON (B)(6) 2007. SUBSEQUENTLY, THE PATIENT UNDERWENT A CLOSED REDUCTION PROCEDURE ON AN UNKNOWN DATE DUE TO DISLOCATION FROM INTERCOURSE.

    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 DUE TO OSTEOARTHRITIS. SUBSEQUENTLY, PATIENT EXPERIENCED DISLOCATION TREATED BY CLOSED REDUCTION PROCEDURE. NO REVISION PROCEDURE WAS REPORTED.

    Description of Event or Problem · 1

    AS PART OF A RETROSPECTIVE CLINICAL STUDY, A PATIENT WAS IDENTIFIED WHO UNDERWENT LEFT FEMORAL RESURFACING ON (B)(6) 2007. SUBSEQUENTLY, THE PATIENT EXPERIENCED A DISLOCATION AND WAS TREATED BY CLOSED REDUCTION PROCEDURE. NO REVISION PROCEDURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401910 RECAP CEMENT FMRL HD RESUR 44M PROSTHESIS, HIP KXA BIOMET ORTHOPEDICS N/A 395830

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization