BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP

    MDR report key: 3781600 · Received April 30, 2014

    Report

    Report Number
    0001825034-2014-03426
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    January 29, 2002
    Report Date
    April 2, 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
    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. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: PRODUCT IDENTIFICATION/EXPIRY DATE, MANUFACTURE DATE. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-00611 & 03426).

    Description of Event or Problem · 1

    BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA REGARDING PATIENTS ENROLLED IN A CLINICAL STUDY. IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED ON THE RIGHT SIDE ON (B)(6) 2006 DUE TO INFECTION. ADDITIONAL INFORMATION RECEIVED FROM PATIENT CLINICAL DATA INDICATES THAT THE INITIAL RIGHT TOTAL HIP ARTHROPLASTY TOOK PLACE ON (B)(6) 2001. PATIENT CLINICAL DATA FURTHER INDICATES THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2002 FOR AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259928 UNKNOWN HIP PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R