BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP CEMENT FMRL HD RESUR 50M

    MDR report key: 3924446 · Received July 9, 2014

    Report

    Report Number
    0001825034-2014-06002
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    November 10, 2013
    Report Date
    September 30, 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. 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. MUSCLE AND FIBROUS TISSUE LAXITY MAY ALSO CONTRIBUTE TO THESE CONDITIONS." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06002 / 1825034-2014-08134).

    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

    CORRECTED DATA: EVENT DESCRIPTION ¿ PATIENT WAS NOT ENROLLED IN A CLINICAL STUDY. A RETROSPECTIVE CLINICAL REVIEW IDENTIFIED THE PATIENT¿S EVENT. ADDITIONAL INFORMATION: DATE OF DISLOCATION AND CLOSED REDUCTION.

    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) 2007 DUE TO OSTEOARTHRITIS. SUBSEQUENTLY, PATIENT EXPERIENCED A HIP DISLOCATION, WHICH WAS TREATED BY CLOSED REDUCTION. NO REVISION HAS BEEN REPORTED.

    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) 2007 DUE TO OSTEOARTHRITIS. SUBSEQUENTLY, THE PATIENT EXPERIENCED A HIP DISLOCATION AND WAS TREATED BY CLOSED REDUCTION ON (B)(6) 2013. NO REVISION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401976 RECAP CEMENT FMRL HD RESUR 50M PROSTHESIS, HIP KXA BIOMET ORTHOPEDICS N/A 505560

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R