BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ALLOFIT

    MDR report key: 19486594 · Received June 7, 2024

    Report

    Report Number
    0009613350-2024-00218
    Event Type
    Injury
    Date Received
    June 7, 2024
    Report Date
    September 16, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). B3: EVENT HAS BEEN ONGOING "SINCE IMPLANTATION." AS SUCH, NO SPECIFIC DATE IS AVAILABLE. G2: REPORT SOURCE GERMANY. 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). D10: ITEM # UNKNOWN, UNKNOWN ALLOCLASSIC SHAFT, LOT # UNKNOWN. ITEM # 173205, SULOX-HD 32 S 12/14, LOT # UNKNOWN. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE PERFORMED DUE TO MISSING LOT NUMBER. DUE TO THE LACK OF PRODUCT REFERENCE AND LOT NUMBERS, IT WAS NOT POSSIBLE TO REVIEW THE COMPLAINT HISTORY. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR THE TREATMENT OF SEVERE RIGHT-SIDED COXARTHROSIS, WITH A SECONDARY DIAGNOSIS OF ARTERIAL HYPERTENSION. UNDERWENT THE IMPLANTATION OF A RIGHT TOTAL HIP REPLACEMENT USING ZIMMER COMPONENTS. POST-OPERATIVELY, SHE REQUIRES CONTINUED OUTPATIENT ORTHOPEDIC FOLLOW-UP, INCLUDING REGULAR CHECK-UPS, LAB TESTS, DRESSING CHANGES, AND REMOVAL OF SUTURES 12-14 DAYS POST-OP. PHYSICAL THERAPY WITH PAIN-ADAPTED FULL WEIGHT-BEARING ON CRUTCHES FOR 4-6 WEEKS IS ADVISED, ALONG WITH PAIN MANAGEMENT AS NEEDED. ADDITIONALLY, CRYOTHERAPY AND LYMPHATIC DRAINAGE ARE RECOMMENDED FOR SWELLING, AND CONTINUED THROMBOEMBOLISM PROPHYLAXIS WITH LOW-MOLECULAR-WEIGHT HEPARIN IS ESSENTIAL. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CANNOT BE CONFIRMED AND A DEFINITE ROOT CAUSE CANNOT BE ESTABLISHED. 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 THE PATIENT HAS HAD PAIN IN THE RIGHT HIP SINCE THE DATE OF IMPLANTATION, APPROXIMATELY 8 YEARS AGO. THE DEVICE WAS INSTALLED CORRECTLY ACCORDING TO THE DOCTOR. 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
    1436961 UNKNOWN ALLOFIT PROSTHESIS, HIP LZO ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other