BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM DIA COCR MOD HD +9MM NK

    MDR report key: 8117375 · Received November 29, 2018

    Report

    Report Number
    3002806535-2018-01223
    Event Type
    Injury
    Date Received
    November 29, 2018
    Date of Event
    March 7, 2017
    Report Date
    June 15, 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
    NL
    Reporter Occupation
    OTHER

    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. 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). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    STUDY PATIENT HAD AN INFECTION. AN ARTHROTOMY OF THE HIP WAS PERFORMED.

    Description of Event or Problem · 0

    STUDY PATIENT HAD AN INFECTION. AN ARTHROTOMY OF THE HIP WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - STANMORE ACET CUP ARCOM 28X53 , ITEM 165782, LOT 3894776, THERAPY DATE - REMAINS IMPLANTED; STANMORE COCR FMRL SZ2 STD, ITEM 164242 , LOT 3954565, THERAPY DATE - REMAINS IMPLANTED. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (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: 3002806535-2018-01221 AND 3002806535-2018-01222.

    Description of Event or Problem · 1

    STUDY PATIENT HAD AN INFECTION. AN ARTHROTOMY OF THE HIP WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957689 28MM DIA COCR MOD HD +9MM NK COCR MODULAR HEADS - PRIMARY JDI BIOMET UK LTD. J3787527

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R