BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 STR MONOBLOCK SHELL INSRTR

    MDR report key: 9139319 · Received October 1, 2019

    Report

    Report Number
    0001825034-2019-04173
    Event Type
    Malfunction
    Date Received
    October 1, 2019
    Date of Event
    July 1, 2019
    Report Date
    February 5, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. BOTH G7 INSERTERS WERE RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION CONFIRMED ONE OF THE THREADED TIPS TO BE FRACTURED SUCH THAT A PORTION OF THE FACE OF THE TIP REMAINS ON THE INSERTER, WHILE THE OTHER ONE FRACTURED COMPLETELY. DINGS AND SCRATCHES WERE OBSERVED ON BOTH HAFT. IMPACT MARKS WERE FOUND ON THE BOTH STRIKE PLATE CONSISTENT WITH A MULTIPLE USE DEVICE. FRACTURE ANALYSIS CONFIRMED THE FRACTURES WERE DUE TO BENDING OVERLOAD OF THE THREADED TIP. THE MATERIAL WAS CONFIRMED TO BE 455 SS. DEVICES HAD AN ESTIMATED FIELD AGE OF 5 AND 3 YEARS, RESPECTIVELY. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 110003450 G7 STR MONOBLOCK SHELL INSRTR 791450. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-04312.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE THREADS ON THE INSERTER WERE DAMAGED. WENT TO USE THE BACK-UP UNIT AND THOSE THREADS WERE DAMAGED ALSO. SURGERY WAS COMPLETED WITHOUT DELAY OR CONSEQUENCE BY USING AN OFFSET INSERTER. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934151 G7 STR MONOBLOCK SHELL INSRTR INSTRUMENT PBI ZIMMER BIOMET, INC. N/A 280280

    Patients

    Seq Age Sex Outcome Treatment
    1