BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA MODULAR CERAMIC FEM HD 36/0MM

    MDR report key: 19141719 · Received April 19, 2024

    Report

    Report Number
    3002806535-2024-00151
    Event Type
    Injury
    Date Received
    April 19, 2024
    Date of Event
    April 26, 2023
    Report Date
    April 26, 2024
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271175
    PMA / PMN Number
    K192683
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 A SHORT DURATION OR YEARS. SYMPTOMS THE PATIENT CAN EXPERIENCE INCLUDE PAIN, TENDERNESS, SWELLING, STIFFNESS, DECREASE IN MOVEMENT, AND/OR REDNESS AT OR AROUND THE JOINT THAT IS INVOLVED. CONSERVATIVE TREATMENT CONSISTS OF OVER THE COUNTER (OTC) MEDICATIONS PAIN RELIEVERS AND ANTI-INFLAMMATORIES, REST, ICE, ELEVATION, AND APPLYING PRESSURE WRAPS. IF CONSERVATIVE TREATMENTS FAIL, PHYSICAL THERAPY, ASPIRATION, ARTHROSCOPY, OR STEROID INJECTIONS MAY BE NECESSARY. THE COMPLAINT INDICATES THAT POSTOP BURSITIS DEVELOPED AND REQUIRED MEDICAL INTERVENTION FOR TREATMENT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D-10: REF. (B)(6) LOT R7301744A G7 3 HOLE, G7 PPS LTD ACET SHELL 54F. REF. (B)(6) LOT 65459622 BONE SCR 6.5X35 SELF-TAP. REF. (B)(6) LOT 65502075 G7 LONGEVITY NEUTRAL 36MM F. REF. (B)(6) LOT 213200 ECHO POR FMRL LAT NC 13X145MM. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL RIGHT HIP TOTAL ARTHROPLASTY PERFORMED APPROXIMATELY 15 MONTHS AGO. SUBSEQUENTLY, THREE MONTHS LATER, THE PATIENT RECEIVED A CORTISONE INJECTION FOR LATERAL HIP PAIN AND TROCHANTERIC BURSITIS. AFTER A YEAR FROM THE INITIAL SURGERY THE PATIENT REPORTED MILD PAIN, MODERATE DIFFICULTIES WITH ACTIVITIES OF DAILY LIVING, SNAPPING SENSATION, AND DIFFICULTY SLEEPING AND WAS PRESCRIBED CORTICOSTEROID INJECTION INTO RIGHT TROCHANTERIC BURSA, A TOPICAL PAIN RELIEF GEL, AND PRESCRIPTION FOR PHYSICAL THERAPY, POSSIBLY DRY NEEDLING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1822845 BIOLOX DELTA MODULAR CERAMIC FEM HD 36/0MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO BIOMET UK LTD. N/A 3128005 00887868271175

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention SEE H11 NARRATIVE.