BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

    MDR report key: 17595663 · Received August 22, 2023

    Report

    Report Number
    0009613350-2023-00481
    Event Type
    Injury
    Date Received
    August 22, 2023
    Report Date
    September 27, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    KTT
    PMA / PMN Number
    NOT CLEARED
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2 - FOREIGN: GERMANY. 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 : PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 0

    (B)(4) THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D2, G3, G4, G6, H2, H3, H6, H10. 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT : PRODUCT INFORMATION AND LOCATION UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED TRACTUS ILIOTIBIALIS IRRITATION THREE MONTHS POST IMPLANTATION. A BURSECTOMY AND REVISION TO REMOVE THE IMPLANT WERE PERFORMED. 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
    1096839 UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE PLATE, FIXATION, BONE KTT ZIMMER SWITZERLAND MANUFACTURING GMBH UNKNOWN
    301682 UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE PLATE, FIXATION, BONE KTT ZIMMER SWITZERLAND MANUFACTURING GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization| R