BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 NEUTRAL E1 LINER

    MDR report key: 6429879 · Received March 23, 2017

    Report

    Report Number
    0001825034-2017-01738
    Event Type
    Injury
    Date Received
    March 23, 2017
    Date of Event
    February 22, 2017
    Report Date
    December 2, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION TO THE CAUSE OF THE EVENT. THE INITIAL IMPLANT DATE FOR THE DEVICES INVOLVED IN THIS EVENT WAS NOT PROVIDED. A REVIEW OF INVOICE HISTORY FOUND TWO POSSIBLE INVOICES. THE SPECIFIC IDENTIFICATION OF THE DEVICE INVOLVED IN THIS EVENT CANNOT BE DETERMINED. IT COULD BE: LOT # - 3240782, EXPIRATION DATE - 31 JAN 2019, UDI# - (B)(4). IMPLANT DATE - (B)(6) 2016. MANUFACTURE DATE - 23 JAN 2014. OR IT COULD BE: LOT # - 3467433, IMPLANT DATE - (B)(6) 2015. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-01528 & 0001825034-2017-01738.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. REVIEW OF THE X-RAY NOTED THE CAUSE FOR REVISION WAS NOT ABLE TO BE IDENTIFIED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A REVISION DUE TO DISLOCATION APPROXIMATELY 10 MONTHS POST IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211438 G7 NEUTRAL E1 LINER HIP PROSTHESIS PBI BIOMET ORTHOPEDICS N/A SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R