BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NCBPP PLATE

    MDR report key: 17937966 · Received October 16, 2023

    Report

    Report Number
    0009613350-2023-00583
    Event Type
    Injury
    Date Received
    October 16, 2023
    Date of Event
    August 23, 2023
    Report Date
    February 12, 2024
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURER GMBH
    Product Code
    HRS
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UPON FURTHER EVALUATION, IT WAS DETERMINED THAT THIS CASE WAS ERRONEOUSLY REPORTED. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF ZIMMER BIOMET, AND THE REPORTED DEVICE CANNOT BE REASONABLY VERIFIED TO BE A CONTRIBUTING FACTOR TO THE REPORTED UNSPECIFIED INFECTION. 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. H3 OTHER TEXT: NOT A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 0

    (B)(4), G2-FOREIGN- AUSTRALIA. ITEM#:110010263 ;LOT#: 6616885 ;ITEM NAME:G7 OSSEOTI MULTIHOLE 50MM D; ITEM#:11-301300 ;LOT#: 669030 ;ITEM NAME: ARCOS CON SZ A STD 50MM. ITEM#:11-300812 ;LOT#: 907920 ;ITEM NAME: ARCOS 12X150MM SPL TPR DIST; ITEM#: 11-107018 ;LOT#: 946110 ;ITEM NAME: FREEDOM CONSTR HD 36MM T1 STD. ITEM#: 010000982;LOT#: 6630227;ITEM NAME: G7 SCREW 6.5MM X 35MM; ITEM#: 010001000;LOT#: 6469604;ITEM NAME: G7 SCREW 6.5MM X 35MM. ITEM#: 010000999;LOT#: 6596558;ITEM NAME: G7 SCREW 6.5MM X 30MM. H3-OTHER: PART# AND LOT# UNKNOWN. ALSO DEVICE LOCATION IS UNKNOWN. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO INFECTION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2144936 UNKNOWN NCBPP PLATE PROSTHESIS, TRAUMA HRS ZIMMER SWITZERLAND MANUFACTURER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention| H SEE H10 NARRATIVE.