BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM DIA COCR MOD HD +9MM NK

    MDR report key: 8119033 · Received November 30, 2018

    Report

    Report Number
    3002806535-2018-01231
    Event Type
    Injury
    Date Received
    November 30, 2018
    Date of Event
    June 29, 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 INFECTION WAS CONFIRMED BY THE HOSPITAL, HOWEVER WE HAVE NOT RECEIVED PATIENT NOTES 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 FOLLOWING SECTIONS WERE UPDATED: DATE OF REPORT, EVENT, OTHER RELEVANT HISTORY, PMA/510K, TYPE OF REPORTABLE EVENT, IF FOLLOW-UP, WHAT TYPE, DEVICE EVALUATED BY MFR. 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 SUSPICION FOR INFECTION. AN ARTHROTOMY OF THE HIP WAS PERFORMED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT - MULLER CUP 28 X 48MM, ITEM 130918, LOT 3983586. THERAPY DATE - REMAINS IMPLANTED. MEDICAL PRODUCT - STANMORE COCR FMRL SZ2 STD, ITEM 164242, LOT 6013739. 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: 3002806535-2018-01229 AND 3002806535-2018-01230.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960139 28MM DIA COCR MOD HD +9MM NK COCR MODULAR HEADS - PRIMARY JDI BIOMET UK LTD. 00J3104377

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R