BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA LNR 36MM 54-56MM

    MDR report key: 9595549 · Received January 16, 2020

    Report

    Report Number
    3002806535-2020-00027
    Event Type
    Injury
    Date Received
    January 16, 2020
    Report Date
    March 13, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00025-1, AND 3002806535-2020-00026-1. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. H3 OTHER TEXT : DEVICES REMAIN IMPLANTED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE THAT THE PATIENT ALLEGEDLY EXPERIENCED UNKNOWN DAMAGES. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENTS NOTICE AND THE ALLEGATIONS THERE IN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: DELTA CER FM HD, CATALOG #: 650-0837, LOT #: 2015020758, MEDICAL PRODUCT: EXCEED ABT 3HL SHELL, CATALOG #: 124454, LOT #: 3505390, MEDICAL PRODUCT: PPF LTZ STEM BMSTR, CATALOG #: 71-001-00305BM, LOT #: 2015020924. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00025, 3002806535-2020-00026. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE THAT THE PATIENT ALLEGEDLY EXPERIENCED UNKNOWN DAMAGES. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENTS NOTICE AND THE ALLEGATIONS THERE IN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59900 BIOLOX DELTA LNR 36MM 54-56MM HIP ARTHROPLASTY JDI BIOMET UK LTD. N/A 3510003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other