BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 DUAL MOBILITY LINER 46MM G

    MDR report key: 6885896 · Received September 22, 2017

    Report

    Report Number
    0001825034-2017-07046
    Event Type
    Injury
    Date Received
    September 22, 2017
    Date of Event
    June 13, 2017
    Report Date
    November 9, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    PK150522
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTIONS ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 110010267, G7 OSSEOTI MULTIHOLE 58MM G, 3891352. EP-200152, ACT ARTIC E1 HIP BRG 28X46MM, 051140. 0100561317, WAGNER CONE PROSTHESIS®, 2860089. 00489430000, ACETABULAR REVISION SYSTEM, 63060630. 00877702802, BIOLOX® OPTION HEAD, 2891878. 00662406525, BONE SCREW SELF-TAPPING 25 MM LENGTH 6.5 MM DIA, 63596947. 00662406530, BONE SCREW SELF-TAPPING 30 MM LENGTH 6.5 MM DIA, 63401095. 00662406540, BONE SCREW SELF-TAPPING 40 MM LENGTH 6.5 MM DIA, 63615169. 00662406535, BONE SCREW SELF-TAPPING 35 MM LENGTH 6.5 MM DIA, 62766982. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 07047, 0001825034 - 2017 - 07048.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT LEFT HIP REVISION APPROXIMATELY ONE MONTH POST-IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668114 G7 DUAL MOBILITY LINER 46MM G PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A 146430

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R