BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCEPTION RASP SIZE 6 RIGHT

    MDR report key: 8614657 · Received May 16, 2019

    Report

    Report Number
    3006946279-2019-00262
    Event Type
    Injury
    Date Received
    May 16, 2019
    Date of Event
    April 10, 2018
    Report Date
    August 28, 2019
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LPH
    UDI-DI
    03599870061824
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D2, G4 H2, H3, H6, H10. THE EVENT COULD NOT BE CONFIRMED. THE DEVICE MANUFACTURING QUALITY RECORD COULD NOT BEEN REVIEWED AS THE LOT NUMBER OF THE PRODUCT WERE NOT COMMUNICATED. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. THEREFORE IT COULD NOT BE ANALYZED. THE COMPLAINTS REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT COMMUNICATED. WITH THE AVAILABLE INFORMATION, THE EXACT ROOT CAUSE OF THE EVENT COULD NOT 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.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS ONGOING. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 · 1

    IT WAS REPORTED THAT THE DURING SURGERY THERE WAS FRACTURE OF RASP AT JUNCTION BETWEEN THE RASP HOLDER AND THE UPPER PART OF THE RASP. THERE WAS DIFFICULTY IN THE RETRIEVAL OF THE BLOCKED RASP WITH FEMUR FISSURE WHICH REQUIRED INSTALLATION OF 2 CERCLAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410828 EXCEPTION RASP SIZE 6 RIGHT HIP INSTRUMENT LPH BIOMET FRANCE S.A.R.L. NOT COMMUNICATED 03599870061824

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization