BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 OSSEOTI 4 HOLE SHELL 54MM F

    MDR report key: 8932900 · Received August 26, 2019

    Report

    Report Number
    0001825034-2019-03760
    Event Type
    Malfunction
    Date Received
    August 26, 2019
    Date of Event
    August 7, 2019
    Report Date
    December 19, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K140669
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM #: UNKNOWN HEAD LOT #: UNKNOWN. ITEM #: UNKNOWN STEM LOT #: UNKNOWN. 010000850 G7 NEUTRAL E1 LINER 32 MM F 3841534. 010000850 G7 NEUTRAL E1 LINER 32 MM F 6074805. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 03757 LINER 1. 0001825034 - 2019 - 03758 LINER 2.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO G7 E1 LINERS WOULD NOT ASSEMBLE WITH G7 ACETABULAR SHELL. SURGERY WAS FINISHED WITH BACKUP PRODUCT. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723794 G7 OSSEOTI 4 HOLE SHELL 54MM F PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 6416552

    Patients

    Seq Age Sex Outcome Treatment
    1