BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOBON

    MDR report key: 6010627 · Received October 7, 2016

    Report

    Report Number
    3006946279-2016-00362
    Event Type
    Injury
    Date Received
    October 7, 2016
    Report Date
    April 13, 2017
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LYC
    PMA / PMN Number
    PK980679
    Removal / Correction Number
    FR 2015-03
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. DATE OF EVENT - NI. EXPIRATION DATE - NI. DATE IMPLANTED - NI. PMA 510(K): THIS PRODUCT IS NOT CLEARED OR DISTRIBUTED IN THE U.S; HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN THE US MANUFACTURES A SIMILAR DEVICE UNDER 510K NUMBER K110449. MANUFACTURE DATE ¿ NI. CORRECTIVE ACTION WAS INITIATED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). QUANTITY - 3. IT HAS BEEN INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED, AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTRIBUTE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT ALLEGES THAT PATIENT RECEIVED A SYNTHETIC BONE GRAFT IMPLANT THAT WAS PART OF A FIELD SAFETY ACTION. PATIENT'S LEGAL COUNSEL FURTHER ALLEGES PATIENT IS EXPERIENCING UNSPECIFIED COMPLICATIONS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT ALLEGES THAT PATIENT RECEIVED A SYNTHETIC BONE GRAFT IMPLANT THAT WAS PART OF A FIELD SAFETY ACTION. PATIENT'S LEGAL COUNSEL FURTHER ALLEGES PATIENT IS EXPERIENCING UNSPECIFIED COMPLICATIONS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY TWO MONTHS POST-IMPLANTATION DUE TO INFECTION AND NON-INTEGRATION OF THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662551 ENDOBON BONE GRAFTING MATERIAL, SYNTHETIC LYC BIOMET FRANCE S.A.R.L. N/A U0172286

    Patients

    Seq Age Sex Outcome Treatment
    1 Other