BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-MOD HUM HEAD 48DIAX19MM

    MDR report key: 7287403 · Received February 21, 2018

    Report

    Report Number
    0001825034-2018-01265
    Event Type
    Injury
    Date Received
    February 21, 2018
    Report Date
    September 6, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWT
    PMA / PMN Number
    PK030710
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: PT-113950, PT HYBRID GLEN POST REGENEREX, 792800, 113954, MD HYBRID GLENOID BASE 4MM, 731600, 11-113708, BIO-MOD ST.12X115 W/ALIGN HOLE, 370860. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001825034 - 2018 - 00778, 0001825034 - 2018 - 00777, 0001825034 - 2018 - 00779. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING PAIN AND A BURNING SENSATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128604 BIO-MOD HUM HEAD 48DIAX19MM PROSTHESIS, SHOULDER KWT ZIMMER BIOMET, INC. N/A 616250

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O