BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM PRESS-FIT COLLARLESS 12/14 NECK TAPER STANDARD BODY

    MDR report key: 15598938 · Received October 13, 2022

    Report

    Report Number
    0001822565-2022-02932
    Event Type
    Injury
    Date Received
    October 13, 2022
    Date of Event
    August 29, 2022
    Report Date
    October 13, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00889024139268
    PMA / PMN Number
    K200823
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 110010262, G7 OSSEOTI MULTIHOLE 48MM, C- 6882082. 30123203, G7 VIT E HIGH WALL LNR 32MM, C- 65056192. 00877503201, BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, ø 32/-3.5, TAPER 12/14, 3043613. 00625006520, BONE SCR 6.5X20 SELF-TAP, J6864840. 00625006535, BONE SCR 6.5X35 SELF-TAP, J6950812. BURSITIS IS THE INFLAMMATION OR IRRITATION OF THE BURSAE (THE FLUID FILLED SAC THAT CUSHIONS THE JOINT) AND IS TYPICALLY CAUSED BY REPETITIVE MOTION, OVERUSE AND PRESSURE TO THE BURSAE. BURSITIS IS A VERY COMMON CONDITION THAT CAN IMPACT ANY OF THE JOINTS AND CAN LAST FOR SHORT DURATION TO YEARS. BURSITIS CAUSE CAN BE UNKNOWN, BUT SOME COMMON CONDITIONS THAT CAN LEAD TO BURSITIS, NOT ALL INCLUSIVE; AUTOIMMUNE DISORDERS SUCH AS RHEUMATOID ARTHRITIS, INFECTION, ARTHRITIS, TRAUMA, DIABETES, THYROID DISEASE, JOINT SURGERY OR JOINT IMPLANTS, ALONG WITH DIFFERENT MEDICATIONS. SYMPTOMS THE PATIENT CAN EXPERIENCE, PAIN, TENDERNESS, SWELLING, STIFFNESS, DECREASE IN MOVEMENT, AND/OR REDNESS AT OR AROUND THE JOINT THAT IS INVOLVED. BURSITIS IS MORE COMMON IN WOMEN, MIDDLE AGED ADULTS AND THE ELDERLY. 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 BURSITIS CAN CONSIST OF, OTC MEDICATIONS, SUCH AS TYLENOL AND ANTI-INFLAMMATORIES, PRESCRIBED PAIN MEDICATIONS, PHYSICAL THERAPY, ARTHROSCOPY OF THE JOINT, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT NEEDED A CORTISONE INJECTION APPROXIMATELY 1-YEAR POST IMPLANTATION FOR TROCHANTERIC BURSITIS. NO ADDITIONAL INFORMATION ON THE REPORTED IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2583360 FEMORAL STEM PRESS-FIT COLLARLESS 12/14 NECK TAPER STANDARD BODY PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 64999788 00889024139268

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Other