BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 STR MONOBLOCK SHELL INSRTR

    MDR report key: 7478883 · Received May 2, 2018

    Report

    Report Number
    0001825034-2018-02538
    Event Type
    Injury
    Date Received
    May 2, 2018
    Date of Event
    April 4, 2018
    Report Date
    December 27, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS CONFIRMED BASED ON THE PHOTOGRAPHS PROVIDED. THE PHOTOGRAPHS OF THE PRODUCT COVERED WITH BLOOD WERE PROVIDED AND IT WAS IDENTIFIED THE THREADS OF THE INSERTER TIP WAS BROKEN AND PART OF IT IS RETAINED IN THE SHELL. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO RELATED DEVIATIONS/ ANOMALIES WERE IDENTIFIED THAT AFFECT THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE 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 · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 110017105, G7 FINNED 4 HOLE SHELL 56F, 6161019. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CUP INSERTION OR REPOSITIONING THE IMPACTOR THREAD TIP SHEARED OFF FROM THE SHELL DURING LEFT TOTAL HIP ARTHROPLASTY. A FOREIGN OBJECT FELL INTO THE PATIENT AND WAS RETRIEVED. PRODUCT CAUSED/CONTRIBUTED TO A SERIOUS INJURY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322364 G7 STR MONOBLOCK SHELL INSRTR SURGICAL, INSTRUMENT LXH ZIMMER BIOMET, INC. N/A 646890

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention