BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM MOD HD STD NECK TP1 TAPER

    MDR report key: 7875223 · Received September 13, 2018

    Report

    Report Number
    3002806535-2018-01074
    Event Type
    Injury
    Date Received
    September 13, 2018
    Date of Event
    April 23, 2018
    Report Date
    April 10, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. 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 BY THE CLINICAL STUDY DEPARTMENT THAT A PATIENT UNDERWENT AN INITIAL LEFT HIP ARTHROPLASTY. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO BURSITIS.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - MLRY-HD POR FMRL 9X150MM, ITEM 11-104109, LOT 522962. CONCOMITANT MEDICAL PRODUCTS - THERAPY DATE - (B)(6) 2018. CONCOMITANT MEDICAL PRODUCTS- M/H SLD/APX HLE RNGLC SHL 52MM, ITEM 11-104052, LOT # UNKNOWN. CONCOMITANT MEDICAL PRODUCTS - THERAPY DATE - (B)(6) 2018. (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2018-01073 AND 3002806535-2018-01075.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICAL STUDY DEPARTMENT THAT A PATIENT UNDERWENT AN INITIAL LEFT HIP ARTHROPLASTY. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED 2018 DUE TO BURSITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713048 28MM MOD HD STD NECK TP1 TAPER JDI BIOMET UK LTD. 0000076660

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R