BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM DIA COCR MOD HD -3MM NK

    MDR report key: 8109654 · Received November 28, 2018

    Report

    Report Number
    3002806535-2018-01214
    Event Type
    Injury
    Date Received
    November 28, 2018
    Date of Event
    July 26, 2017
    Report Date
    June 22, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    K953925
    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. 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). 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 WOUND LEAKAGE AND INFECTION. AN ARTHROTOMY OF THE HIP WAS PERFORMED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT - MULLER CUP 28 X 48MM , ITEM 130918, LOT 6033187. 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.

    Description of Event or Problem · 1

    STUDY PATIENT (B)(6) HAD WOUND LEAKAGE AND INFECTION. AN ARTHROTOMY OF THE HIP WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951096 28MM DIA COCR MOD HD -3MM NK COCR MODULAR HEADS - PRIMARY LZO BIOMET UK LTD. RAJ3918643

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R