BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER BIOMET CERAMIC HEAD

    MDR report key: 19614723 · Received June 26, 2024

    Report

    Report Number
    0001822565-2024-02144
    Event Type
    Injury
    Date Received
    June 26, 2024
    Date of Event
    April 17, 2024
    Report Date
    September 6, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00887868376689
    PMA / PMN Number
    K200823
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). TENDONITIS IS THE INFLAMMATION OR IRRITATION OF THE TENDONS AND IS TYPICALLY CAUSED BY REPETITIVE MOTION, OVERUSE AND PRESSURE TO THE BURSAE. SYMPTOMS THE PATIENT CAN EXPERIENCE, PAIN, TENDERNESS, SWELLING, STIFFNESS, DECREASE IN MOVEMENT, AND/OR REDNESS AT OR AROUND THE JOINT THAT IS INVOLVED. THIS CAN IMPACT THE PATIENTS¿ ABILITY TO USE THE JOINT TO THEIR FULL POTENTIAL. PATIENT CAN EXPERIENCE A DECREASE WITH OVERALL ADLS, ROM OF THE JOINT, DECREASE IN QUALITY OF LIFE, AS WELL AS INCREASING THE NEED FOR POSSIBLE OVER THE COUNTER (OTC) MEDICATIONS FOR SWELLING AND PAIN CONTROL. TREATMENT FOR TENDONITIS CAN CONSIST OF, OTC MEDICATIONS, SUCH AS TYLENOL AND ANTI-INFLAMMATORIES, PRESCRIBED PAIN MEDICATIONS, PHYSICAL THERAPY, REST, ICE, ELEVATING THE AFFECTED JOINT AND STEROID INJECTIONS. 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 CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION DUE TO HOSPITAL POLICY. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY THREE YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A LEFT HIP REVISION DUE TO PSOAS TENDONITIS. THE HEAD WAS SWAPPED FOR ANOTHER OF THE SAME SIZE DUE TO EXPOSURE PURPOSES. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674187 ZIMMER BIOMET CERAMIC HEAD PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 3048259 00887868376689

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R