BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN NCB PLATE

    MDR report key: 15822308 · Received November 18, 2022

    Report

    Report Number
    0009613350-2022-00591
    Event Type
    Death
    Date Received
    November 18, 2022
    Report Date
    January 19, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURER GMBH
    Product Code
    HRS
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE: (B)(6). LITERATURE- JOURNAL ARTICLE: COMPARISON OF THE FUNCTIONAL OUTCOMES AFTER TREATMENT OF PERIPROSTHETIC HIP FRACTURES WITH FEMORAL STEM LOOSENING: LOCKING PLATE FIXATION WITH OR WITHOUT FEMORAL STEM REVISION. TRISTAN VIALLA, DONG TRAN-MINH, FLORIAN BARBOTTE, ALEXANDRE HERAULT ,MATTHIEU EHLINGER, XAVIER OHL, HENRI FAVREAU, RENAUD SIBONI. HTTPS://DOI.ORG/10.1016/J.OTSR.2022.103300. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. NO FURTHER DISCUSSION OR INFORMATION WAS PROVIDED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF THE DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. THE DEVICE IS USED FOR TREATMENT. A COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED WITHOUT PART AND LOT IDENTIFICATION. MEDICAL RECORDS WERE NOT PROVIDED. 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.

    Description of Event or Problem · 0

    A STUDY REPORTED 1 PATIENT, WITHIN THE FEMORAL STEM REVISION (FSR) GROUP, HAD A TOTAL HIP ARTHROPLASTY AND MONTHS LATER, UNDERWENT A REVISION OF THE FEMORAL STEM AND IMPLANTATION OF A LOCKING PLATE FIXATION SYSTEM DUE TO A PERIPROSTHETIC FRACTURE AND FEMORAL STEM LOOSENING. SUBSEQUENTLY, THE PATIENT EXPIRED DURING THE IMMEDIATE POST-OP PERIOD. NO FURTHER INFORMATION WAS PROVIDED. 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
    323025 UNKNOWN NCB PLATE TRAUMA PROSTHESIS HRS ZIMMER SWITZERLAND MANUFACTURER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Death