BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRABECULAR METAL FEMORAL STEM STANDARD BODY EXTENDED NECK OFFSET SZ14 149MM

    MDR report key: 19105114 · Received April 15, 2024

    Report

    Report Number
    0001822565-2024-01164
    Event Type
    Injury
    Date Received
    April 15, 2024
    Date of Event
    March 27, 2024
    Report Date
    April 15, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024139282
    PMA / PMN Number
    K051491
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 110010266 LOT# 65077091 G7 OSSEOTI MULTIHOLE 56MM F; CAT# 00625006540 LOT# J6793100 BONE SCR 6.5X40 SELF-TAP; CAT# 00625006535 LOT# J7214197 BONE SCR 6.5X35 SELF-TAP; CAT# 20123606 LOT# 65357680 G7 LONGEVITY HIGH WALL 36MM F; CAT# 00877503602 LOT# 3093820 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14. 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. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE UNRELATED TO THE IMPLANTED ZIMMER BIOMET DEVICE; THE REPORTED EVENT (BURSITIS) IS A PROCEDURE RELATED COMPLICATION AND NOT DEVICE RELATED; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT PERFORMED. PRODUCT REMAINS IMPLANTED AND WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 THAT APPROXIMATELY 2 YEARS POST IMPLANTATION OF A LEFT TOTAL HIP ARTHROPLASTY, THE PATIENT RECEIVED A CORTISONE INJECTION FOR MILD PAIN IN THE TROCH BURSA, WHICH RELIEVED THE PAIN. THE SURGEON REPORTED THAT TROCHANTERIC BURSITIS IS EXTREMELY COMMON AFTER HIP REPLACEMENT AND IS NOT CONSIDERED A COMPLICATION. THERE WERE NO PRECEDENT FACTORS FOR THIS PATIENT OTHER THAN NORMAL EVERYDAY USE OF THE HIP. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1470790 TRABECULAR METAL FEMORAL STEM STANDARD BODY EXTENDED NECK OFFSET SZ14 149MM PROTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 65353401 00889024139282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other