BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLC BMPC LAT 9.0X137 12/14

    MDR report key: 8910033 · Received August 20, 2019

    Report

    Report Number
    3002806535-2019-00651
    Event Type
    Injury
    Date Received
    August 20, 2019
    Date of Event
    September 22, 2018
    Report Date
    August 23, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    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. 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 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). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: MLRY-HD 3HOLE RLC SHL 60MM/L23, CATALOG #: 11-104160, LOT #: 3200305; 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00013, 3002806535-2019-00014, 3002806535-2019-00015. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE PATIENT'S LEGAL ATTORNEY THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO 'WEAR OF POLYETHYLENE FOLLOWING THE LEFT HIP'S REPLACEMENT SURGERY' (IN THE CLINICAL RECORDS BOTH PAIN AND NOISE FROM THE LEFT HIP ARE REPORTED). 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
    706280 TAPERLC BMPC LAT 9.0X137 12/14 HIP PROSTHESIS JDI BIOMET UK LTD. N/A 3312045

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R