BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 DUAL MOBILITY LINER 46MM G

    MDR report key: 7768646 · Received August 9, 2018

    Report

    Report Number
    0001825034-2018-07870
    Event Type
    Injury
    Date Received
    August 9, 2018
    Date of Event
    July 12, 2017
    Report Date
    October 16, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK150522
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. UNIQUE IDENTIFIER (UDI) #: N/A. CONCOMITANT MEDICAL PRODUCTS: ITEM # UNK, STEM, LOT # UNK; ITEM # 650-1055, HEAD, LOT # 2887342; ITEM # EP-200152, SHELL, LOT # 902290; ITEM # 650-1067, TAPER SLEEVE, LOT # 2887431. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 07871; 0001825034 - 2018 - 07872; 0001825034 - 2018 - 07873.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 2 MONTHS POST IMPLANTATION/REVISION, THE PATIENT WAS REVISED AGAIN DUE TO INSTABILITY AND FAILED ABDUCTOR REPAIR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611143 G7 DUAL MOBILITY LINER 46MM G PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 642280

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R