BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

    MDR report key: 17594784 · Received August 22, 2023

    Report

    Report Number
    0009613350-2023-00479
    Event Type
    Injury
    Date Received
    August 22, 2023
    Report Date
    September 27, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURER GMBH
    Product Code
    KTT
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2-FOREIGN-GERMANY. H3-OTHER: DEVICE EVALUATION COULD NOT BE PERFORMED AS PART# AND LOT# UNKNOWN. ALSO DEVICE LOCATION IS UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. G4: THIS PRODUCT IS NOT CLEARED IN THE US, HOWEVER, IS CONSIDERED EQUIVALENT TO 510K K000734. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF MANUFACTURING RECORDS CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. DEVICE IS USED FOR TREATMENT. MEDICAL RECORDS WERE NOT PROVIDED. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT 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 · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION, 14 DAYS POST OPERATIVELY WHICH LED TO REVISION SURGERY. DURING REVISION SURGERY DEBRIDEMENT AND EXCHANGE OF ALL PARTS WAS DONE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096837 UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE PLATE, FIXATION, BONE KTT ZIMMER SWITZERLAND MANUFACTURER GMBH UNKNOWN
    311308 UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE PLATE, FIXATION, BONE KTT ZIMMER SWITZERLAND MANUFACTURER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Required Intervention| H