BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BI METRIC INTERLOC STEM

    MDR report key: 6774443 · Received August 8, 2017

    Report

    Report Number
    0001825034-2017-06092
    Event Type
    Injury
    Date Received
    August 8, 2017
    Date of Event
    November 3, 2016
    Report Date
    August 21, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDL
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. (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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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.

    Description of Event or Problem · 1

    IT IS REPORTED 10 PATIENT REVISIONS CASES OF LOOSE STEMS IN CEMENT MANTLE. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553984 UNKNOWN BI METRIC INTERLOC STEM PROSTHESIS, HIP JDL BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R