BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 STRAIGHT MONOBLOCK ACETABULAR SHELL INSERTER

    MDR report key: 6153297 · Received December 7, 2016

    Report

    Report Number
    0001825034-2016-05101
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Report Date
    September 26, 2017
    Manufacturer
    .
    Product Code
    JDI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT MAY OCCUR. UNDER PRECAUTION IT STATES, "INSTRUMENTS THAT HAVE EXPERIENCE EXTENSIVE USE OR EXCESSIVE FORCE ARE SUSCEPTIBLE TO FRACTURE".

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. INSPECTION OF THE RETURNED DEVICE REVEALED SOME WEAR ON THE LEAD THREAD OF THE DISTAL THREADS. HOWEVER, THE THREADS WERE STILL CONFORMING BASED ON A GO/NO GO GAUGE AND APPEAR TO BE FUNCTIONAL. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND RELEVANT TO THE REPORTED EVENT. ROOT CAUSE OF THE EVENT COULD NOT 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 WAS REPORTED THAT DURING INSPECTION THE THREADS OF THE INSERTER WERE NOTED TO HAVE BEEN DAMAGED. THERE WAS NO PATIENT INVOLVEMENT OR DELAY IN A PROCEDURE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803265 G7 STRAIGHT MONOBLOCK ACETABULAR SHELL INSERTER PROTHESIS, HIP JDI . N/A 069500

    Patients

    Seq Age Sex Outcome Treatment
    1