BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MLRY-HD 3HOLE RLC SHL 60MM/L23

    MDR report key: 8221788 · Received January 7, 2019

    Report

    Report Number
    3002806535-2019-00013
    Event Type
    Injury
    Date Received
    January 7, 2019
    Date of Event
    September 22, 2018
    Report Date
    August 23, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO 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 · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: TAPERLC BMPC LAT 9.0X137 12/14 CATALOG #: 650-0562BM LOT #: 3312045, MEDICAL PRODUCT: DELTA CER FM HD 036/-4MM 12/14 CATALOG #: 650-0836 LOT #: 3529937, MEDICAL PRODUCT: RLOC-X E1 H/W +3MM 50/36MM 23 CATALOG #: EP-083650 LOT #: 3549268. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (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. 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 · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT HIP REPLACEMENT SURGERY . SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO IMPLANT WEAR. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENTS NOTICE AND THE ALLEGATIONS THERE IN ARE UNVERIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT HIP REPLACEMENT SURGERY . SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO POLYETHYLENE IMPLANT WEAR. 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, FOREIGN - EVENT OCCURRED IN (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00014 AND 0001825034-2019-00015. 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 WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT HIP REPLACEMENT SURGERY ON (B)(6) 2015. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2018 DUE TO IMPLANT WEAR. 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
    13839 MLRY-HD 3HOLE RLC SHL 60MM/L23 PROSTHESIS, HIP LZO BIOMET UK LTD. N/A 3200305

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R