BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    UNKNOWN REVITAN-MODULAR FLUTED TAPERED STEM

    MDR report key: 20384980 · Received October 7, 2024

    Report

    Report Number
    0009613350-2024-00480
    Event Type
    Injury
    Date Received
    October 7, 2024
    Date of Event
    April 1, 2024
    Report Date
    March 25, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: G3; H2; H6 A HEMATOMA IS A MASS OF CLOTTED BLOOD THAT FORMS IN A TISSUE, ORGAN, OR BODY SPACE. A HEMATOMA CAN BE ASSOCIATED WITH PAIN, SWELLING, ECCHYMOSIS, SEROSANGUINOUS OR BLOODY DRAINAGE AFTER A RECENT SURGICAL PROCEDURE OR TRAUMA AND CAN PREDISPOSE THE PATIENT TO INFECTION. THE DEVELOPMENT OF A POSTOPERATIVE HEMATOMA CAN BE CORRELATED WITH THE SURGICAL PROCEDURE AND PERIOPERATIVE ANTICOAGULATION THERAPY PRESCRIBED TO PREVENT THROMBUS FORMATION. MOST HEMATOMAS RESOLVE ON THEIR OWN, WITHOUT SURGICAL INTERVENTION, WHILE SOME DO NOT. LARGER HEMATOMAS MAY NEED TO BE SURGICALLY EVACUATED IN ORDER TO RESOLVE. AS TIMEFRAMES OF ONSET DIFFER DUE TO INDIVIDUAL CONTRIBUTING FACTORS, A SPECIFIC TIMEFRAME OF EXPECTED OCCURRENCE 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.

    Additional Manufacturer Narrative · 0

    (B)(4). G2. REPORT SOURCE: GERMANY. LITERATURE: REVISION TOTAL HIP ARTHROPLASTY USING A MODULAR FLUTED, TAPERED REVISION FEMORAL COMPONENT AND INTERLOCKING SCREWS IN VANCOUVER B3 PERIPROSTHETIC FRACTURES WITH INSUFFICIENT BONE AT THE ISTHMUS. B. FINK; A. AHMADIAN; F. H. SAX; P. SCHUSTER. THE BONE AND JOINT JOURNAL. PAGES (1-8). 2024. DOI: 10.1302/0301-620X.106B4.BJJ-2023-0899.R1. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT THERE WAS ONE PATIENT THAT DEVELOPED A HEMATOMA THAT REQUIRED AN EVACUATION TWO WEEKS POST-OPERATIVE. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247711 UNKNOWN REVITAN-MODULAR FLUTED TAPERED STEM PROSTHESIS, HIP LZO ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H