BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD MOD HD 38MM +6 NK

    MDR report key: 9278056 · Received November 5, 2019

    Report

    Report Number
    3002806535-2019-00839
    Event Type
    Injury
    Date Received
    November 5, 2019
    Date of Event
    October 1, 2019
    Report Date
    November 14, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    UDI-DI
    05019279316182
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 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.

    Description of Event or Problem · 0

    IT IS REPORTED THAT A PATIENT UNDERWENT INITIAL LEFT HIP SURGERY AND IS SUBSEQUENTLY EXPERIENCING PAIN FOR AN UNKNOWN REASON

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN THE (B)(6). CONCOMITANT MEDICAL PRODUCTS: BI-METRIC HA/PC 16X160MM T1, CATALOG #: 162036, LOT #: 1496250; M2A 1 PC SHELL 38MMX54MM, CATALOG #: 5-105054, LOT #: 311140. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00838. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A PATIENT UNDERWENT INITIAL LEFT HIP SURGERY AND IS SUBSEQUENTLY EXPERIENCING PAIN FOR AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073047 CER BIOLOXD MOD HD 38MM +6 NK HIP PROSTHESIS JDI BIOMET UK LTD. N/A 1620332 05019279316182

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization