BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN CO CR HEAD

    MDR report key: 6776600 · Received August 9, 2017

    Report

    Report Number
    0001825034-2017-06153
    Event Type
    Malfunction
    Date Received
    August 9, 2017
    Date of Event
    November 3, 2016
    Report Date
    August 22, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REPORT REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT WAS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). BORGWARDT, A. ET AL (2016) A RANDOMISED, CONTROLLED CLINICAL STUDY ON TOTAL HIP ARTHROPLASTY USING 4 DIFFERENT BEARINGS: RESULTS AFTER 10 YEARS. HIP INTERNATIONAL 2017; 27 (1): 96-103. DOI: 10.5301/HIPINT.5000428. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-06154, 0001825034-2017-06155.

    Description of Event or Problem · 1

    IT IS REPORTED THAT 33 DISLOCATIONS OCCURRED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562892 UNKNOWN CO CR HEAD PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other