BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-POLY 32MM +3 HIWALL LNR SZ22

    MDR report key: 3790555 · Received May 5, 2014

    Report

    Report Number
    0001825034-2014-03592
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    November 27, 2013
    Report Date
    May 20, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MAY
    PMA / PMN Number
    PK090103
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED NOTIFICATION DATE WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    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. 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 5 OF 7 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-02645 / 02646 & 03589 / 03590 & 03592 / 03593 & 03596).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2013. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2013 DUE TO DISLOCATION. THE MODULAR HEAD WAS REMOVED AND REPLACED. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2013 DUE TO DISLOCATION. THE MODULAR HEAD WAS REMOVED AND REPLACED. IT WAS FURTHER REPORTED PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2013 DUE TO DISLOCATION. THE MODULAR HEAD AND LINER WERE REMOVED AND REPLACED. ADDITIONALLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2013 DUE TO DISLOCATION. THE LINER WAS REMOVED AND REPLACED. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO DISLOCATION. THE MODULAR HEAD AND LINER WERE REMOVED AND REPLACED WITH CUSTOM COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268289 E-POLY 32MM +3 HIWALL LNR SZ22 PROSTHESIS, HIP MAY BIOMET ORTHOPEDICS N/A 927560

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R