BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI 4 HOLE SHELL 62MM H

    MDR report key: 6652938 · Received June 20, 2017

    Report

    Report Number
    0001825034-2017-04087
    Event Type
    Injury
    Date Received
    June 20, 2017
    Date of Event
    May 26, 2017
    Report Date
    April 3, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK140669
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. 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

    CMP-(B)(4). CONCOMITANT PRODUCTS: -G7 NEUTRAL E1 LINER 36MM H/ PN 010000860/ LN 3929885, G7 NEUTRAL E1 LINER 36MM H/ PN 010000860/ LN 3491004, G7 OSSEOTI 4 HOLE SHELL 62MM H/ PN 110010249/ LN R3618024A. 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: 0001825034-2017-04088, 0001825034-2017-03910, 0001825034-2017-03911.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY A ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON IMPLANTED A SHELL AND WAS UNABLE TO GET THE LINER TO SEAT. THE FIRST SHELL WAS REMOVED AND SECOND SHELL WAS IMPLANTED. ONCE AGAIN THE SURGEON COULD NOT GET EITHER LINER TO PROPERLY SEAT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT CUP ALTOGETHER. A DELAY OF BETWEEN 30 AND 60 MINUTES WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434954 G7 OSSEOTI 4 HOLE SHELL 62MM H PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 3588531

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other SEE H10 NARRATIVE