BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN NCB PLATE

    MDR report key: 15823729 · Received November 18, 2022

    Report

    Report Number
    0009613350-2022-00589
    Event Type
    Death
    Date Received
    November 18, 2022
    Report Date
    January 16, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HRS
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE: FOREIGN - FRANCE. TRISTAN VIALLAA, DONG TRAN-MINHA, FLORIAN BARBOTTEA, ALEXANDRE HERAULT, MATTHIEU EHLINGER, XAVIER OHL, HENRI FAVREAUB, RENAUD SIBONI (2022). COMPARISON OF THE FUNCTIONAL OUTCOMES AFTER TREATMENT OF PERIPROSTHETIC HIP FRACTURES WITH FEMORAL STEM LOOSENING: LOCKING PLATE FIXATION WITH OR WITHOUT FEMORAL STEM REVISION. ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH, 108(2022),743-748, HTTPS://DOI.ORG/10.1016/J.OTSR.2022.103300. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. 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. DEVICE IS USED FOR TREATMENT. 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

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT TWO PATIENTS UNDERWENT IMPLANTATION OF A LOCKING PLATE FIXATION SYSTEM DUE TO A PERIPROSTHETIC FRACTURE. SUBSEQUENTLY, THE PATIENTS EXPIRED DURING THE POST-OPERATIVE PHASE. NO FURTHER INFORMATION WAS PROVIDED. DUE DILIGENCE IS IN PROGRESS TO DETERMINE THE CAUSE OF DEATH. AT THIS TIME THE CAUSE OF DEATH IS UNKNOWN, AS SUCH ZIMMER BIOMET IS CONSERVATIVELY REPORTING THIS EVENT.

    Description of Event or Problem · 0

    ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230913 UNKNOWN NCB PLATE TRAUMA PROSTHESIS HRS ZIMMER SWITZERLAND MANUFACTURING GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Death