BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LINER

    MDR report key: 4502187 · Received February 10, 2015

    Report

    Report Number
    0001825034-2015-00512
    Event Type
    Injury
    Date Received
    February 10, 2015
    Date of Event
    January 27, 2015
    Report Date
    January 16, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK070364
    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 RELATED TO THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED DUE TO THE PART/LOT INFORMATION COULD BE: BRAND NAME - EPOLY 28MM RLC LNR MROM SZ22; LOT NUMBER - 374640; EXPIRATION DATE ¿ SEPTEMBER 30, 2017; PMA/510(K) NUMBER - K070364; MANUFACTURE DATE ¿ SEPTEMBER 28, 2012. OR THE PART/LOT INFORMATION COULD BE: BRAND NAME - E-POLY 32MM +3 MAXROM LNR SZ22; CATALOG NUMBER - EP-108222; LOT NUMBER - 236090; EXPIRATION DATE ¿ MAY 31, 2019; PMA/510(K) NUMBER - K090103; MANUFACTURE DATE ¿ MAY 22, 2014. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION, MALALIGNMENT, MALPOSITION, EXCESSIVE UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY, TRAUMA, WEIGHT GAIN, OR OBESITY."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY IN 1990. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO AN UNKNOWN REASON. THE LINER WAS REMOVED AND REPLACED. PATIENT UNDERWENT A FURTHER REVISION PROCEDURE ON (B)(6) 2015 DUE TO DISLOCATION. THE MODULAR HEAD AND LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94512 UNKNOWN LINER PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization| R