BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVENIR STD STEM CEMENTED 2

    MDR report key: 23108844 · Received September 22, 2025

    Report

    Report Number
    0009613350-2025-00719
    Event Type
    Injury
    Date Received
    September 22, 2025
    Date of Event
    December 19, 2024
    Report Date
    December 3, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    K200112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4): D10: ITEM # 47115003963, OPTIPAC 60 REFOB BONE CMT R-3, LOT # AY30AC2103. ITEM # 010000662, G7 PPS LTD ACET SHELL 50D, LOT # 7406405. ITEM # 30123604, 36MM I.D. SIZE D HIGH WALL LINER, LOT # 65257170. ITEM # 802203602, FEMORAL HEAD 12/14 TAPER 36 MM DIAMETER +0 MM NECK LENGTH, LOT # 3103134. G2: REPORT SOURCE DENMARK. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). REVIEW OF THE REPORTED EVENT BY A HEALTH CARE PROFESSIONAL FOUND: BURSITIS IS THE INFLAMMATION OR IRRITATION OF THE BURSAE, TYPICALLY CAUSED BY REPETITIVE MOTION, OVERUSE, AND PRESSURE. IT IS A COMMON CONDITION THAT CAN IMPACT ANY JOINT AND MAY LAST FOR A SHORT DURATION OR YEARS. SYMPTOMS INCLUDE PAIN, TENDERNESS, SWELLING, STIFFNESS, DECREASED MOVEMENT, AND REDNESS AROUND THE AFFECTED JOINT. CONSERVATIVE TREATMENT INCLUDES OTC PAIN RELIEVERS, ANTI-INFLAMMATORIES, REST, ICE, ELEVATION, AND PRESSURE WRAPS. IF THESE FAIL, PHYSICAL THERAPY, ASPIRATION, ARTHROSCOPY, OR STEROID INJECTIONS MAY BE NECESSARY. THE COMPLAINT INDICATES THAT POSTOP BURSITIS DEVELOPED AND REQUIRED MEDICAL INTERVENTION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE UNRELATED TO THE DEVICE. THIS IS A LIMITED INVESTIGATION; A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY REVIEW WILL NOT BE COMPLETED FOR LIMITED INVESTIGATION COMPLAINTS AS THE PRODUCT MEETS THE APPLICABLE ACCEPTANCE CRITERIA. ADDITIONALLY, PART AND LOT/SERIAL IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS AND A COMPLAINT HISTORY REVIEW, LOT NOT PROVIDED. INSUFFICIENT INFORMATION PROVIDED. UNABLE TO PERFORM A COMPATIBILITY CHECK. 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 IN A CLINICAL STUDY THAT A PATIENT DEVELOPED TROCHANTERIC BURSITIS AND WAS GIVEN A NERVE BLOCK AND PRESCRIBED PAIN MEDICATION AND PHYSICAL THERAPY TWENTY-ONE MONTHS AFTER INITIAL LEFT TOTAL HIP ARTHROPLASTY. TWO YEARS POST INITIAL SURGERY THE EVENT WAS RESOLVED AND ALL PRODUCTS REMAIN IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2170170 AVENIR STD STEM CEMENTED 2 PROSTHESIS, HIP LZO ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Other SEE H11 NARRATIVE.