BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 LINER

    MDR report key: 7393890 · Received April 3, 2018

    Report

    Report Number
    0001825034-2018-02275
    Event Type
    Malfunction
    Date Received
    April 3, 2018
    Date of Event
    March 1, 2018
    Report Date
    June 26, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. CONCOMITANT PRODUCTS: ITEM #: 010000997, ITEM NAME: G7 SCREW, LOT #: 3920093; ITEM #: 650-1057, ITEM NAME: BIOLOX DELTA HEAD, LOT #: 2904536; ITEM #: 650-1064, ITEM NAME: CER SLEEVE, LOT #: 2912968; ITEM #: 51-101070, ITEM NAME: TAPERLOC STEM, LOT #: 3963450; ITEM #: 010000664, ITEM NAME: G7 SHELL, LOT #: 6186608.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED LINER SHOWS DEFORMATION TO THE SCALLOPS AROUND THE LINER, ALSO THE GROOVE FEATURE SHOWS INDENTATION ON THE OUTSIDE RADIUS OF THE LINER. NO FURTHER ANALYSIS WAS DONE AS THE LINER WAS IMPACTED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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 DURING A HIP ARTHROPLASTY THE LINER WOULD NOT SEAT WITH THE CUP, ANOTHER LINER WAS USED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237155 G7 LINER PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6202181

    Patients

    Seq Age Sex Outcome Treatment
    1