BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI MULTIHOLE 64MM H

    MDR report key: 6223321 · Received January 4, 2017

    Report

    Report Number
    0001825034-2016-05525
    Event Type
    Injury
    Date Received
    January 4, 2017
    Date of Event
    January 13, 2017
    Report Date
    November 9, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK140669
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - NI, DEVICE PRODUCT CODE - NI, EXPIRATION DATE - NI, DATE IMPLANTED - NI, MANUFACTURE DATE ¿ NI.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: G7 SCREW 6.5 MM X 40 MM P/N 010001001 L/N 3226329, G7 SCREW 6.5 MM X 40 MM P/N 010001001 L/N UNKNOWN, G7 SCREW 6.5 MM X 35 MM P/N 010001000 L/N 3654068, G7 SCREW 6.5 MM X 20 MM P/N 010000997 L/N 3215551, G7 APICAL HOLE PLUG P/N 010000994 L/N 3463331, G7 10 DEG E1 LINER 36 MM H P/N 010000899 L/N 3567933, 36 MM COCR MOD HD +9 MM P/N 11-363665 L/N 1038870, ARCOS 17 X 190 MM SPL TPR DIST P/N 11-300917 L/N 593060, ARCOS CON SZ B HI 80 MM P/N 11-3001352 L/N 605140. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). 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.

    Description of Event or Problem · 1

    PATIENT HAS BEEN INDICATED FOR REVISION DUE TO UNKNOWN REASONS. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Description of Event or Problem · 1

    REVISION DUE TO CUP LOOSENING. CUP, HEAD AND LINER WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4076 G7 OSSEOTI MULTIHOLE 64MM H PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 3575532

    Patients

    Seq Age Sex Outcome Treatment
    1 Other