BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM COCR MOD HD +9MM

    MDR report key: 3771296 · Received April 24, 2014

    Report

    Report Number
    0001825034-2014-03275
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    November 19, 2008
    Report Date
    April 2, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK032396
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS." THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-00587 & 03274 / 03275).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 1995. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2008 DUE TO POLY WEAR. THE MODULAR HEAD AND LINER WERE REMOVED AND REPLACED. IT WAS FURTHER REPORTED PATIENT UNDERWENT CLOSED REDUCTION PROCEDURES ON (B)(6) 2008 AND (B)(6) 2008. SUBSEQUENTLY, PATIENT WAS REVISED ON THE LEFT SIDE ON (B)(6) 2008 DUE TO DISLOCATION AND INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248709 36MM COCR MOD HD +9MM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 886110

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R