BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP

    MDR report key: 3822000 · Received May 20, 2014

    Report

    Report Number
    0001825034-2014-04426
    Event Type
    Injury
    Date Received
    May 20, 2014
    Report Date
    April 22, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. DATE OF EVENT - UNKNOWN. EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. DATE EXPLANTED - UNKNOWN. PMA/510(K) NUMBER - UNKNOWN. MANUFACTURE DATE ¿ UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNKNOWN DATE DUE TO PAIN. IT WAS FURTHER REPORTED THAT PATIENT UNDERWENT A SECOND REVISION PROCEDURE ON (B)(6) 2014 DUE TO BRITTLE BONES AND AN IMPROPERLY HEALING HIP FRACTURE. DURING THE REVISION PROCEDURE, THE SURGEON FOUND THAT THE NAIL HAD FRACTURED IN THE PATIENT. THE SURGEON WAS ABLE TO COMPLETELY REMOVE THE PIECES OF THE NAIL. ADDITIONALLY, ALL COMPONENTS WERE REMOVED AND REPLACED. THERE WAS NO DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299444 UNKNOWN HIP PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R