BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 POROUS PLASMA SPRAY LIMITED ACETABULAR SHELL 50D

    MDR report key: 7603405 · Received June 14, 2018

    Report

    Report Number
    0001825034-2018-04005
    Event Type
    Injury
    Date Received
    June 14, 2018
    Date of Event
    May 16, 2018
    Report Date
    September 13, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    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. 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, DUE TO IMPLANTS BEING DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). MEDICAL DEVICES: 010000982, G7 FREEDOM CONST E1 LNR 36MM D, 3791913, 00811400100, FEMORAL STEM 12/14 NECK TAPER STANDARD OFFSET SIZE 1 130 MM STEM LENGTH, 63277191, 14-107018, FRDM CNSTR HD 36MM T12/14 STD, 833640.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION SURGERY APPROXIMATELY 9 MONTHS POST IMPLANTATION DUE TO A BONE FRACTURE FROM A FALL. THE CAUSE OF THE FALL IS UNKNOWN AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444084 G7 POROUS PLASMA SPRAY LIMITED ACETABULAR SHELL 50D HIP PROSTHESIS PBI ZIMMER BIOMET, INC. N/A 6096524

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R