BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    UNKNOWN REVITAN-MODULAR FLUTED TAPERED STEM

    MDR report key: 20385420 · Received October 7, 2024

    Report

    Report Number
    0009613350-2024-00481
    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: B4, G3, G6, H2, H6, H11. PROCEDURAL RELATED COMPLICATIONS ARE INFLUENCED BY THE TYPE OF SURGERY, PATIENTS PRE-EXISTING COMORBIDITIES, AND PERIOPERATIVE MANAGEMENT. DEEP VEIN THROMBOSIS (BLOOD CLOT), OR DVT, OCCURS WHEN A BLOOD CLOT FORMS IN ONE OF THE DEEP VEINS OF THE BODY. THIS CAN HAPPEN IF A VEIN BECOMES DAMAGED OR IF THE BLOOD FLOW WITHIN A VEIN SLOWS DOWN OR STOPS. TOTAL JOINT PATIENTS ARE TYPICALLY PLACED ON MEDICATION POST-OPERATIVELY TO PREVENT DVT FORMATION. EVEN WITH THE ADMINISTRATION OF PREVENTIVE MEDICATION, DVTS CAN STILL DEVELOP. AS THE COMPLAINT INDICATED, A POST-OPERATIVE COMPLICATION OCCURRED, AND MEDICAL INTERVENTION WAS REQUIRED FOR TREATMENT. 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). D10. UNKNOWN INTERLOCKING SCREWS LOT# UNKNOWN ITEM# UNKNOWN. 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

    DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT THERE WAS ONE PATIENT WITHIN THE PAPROSKY TYPE IIIB DEFECT GROUP THAT DEVELOPED A DEEP VEIN THROMBOSIS AT AN UNKNOWN TIMEFRAME AND WAS SUCCESSFULLY TREATED WITH MEDICATION. 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
    2547370 UNKNOWN REVITAN-MODULAR FLUTED TAPERED STEM PROSTHESIS, HIP LZO ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| O SEE H11 NARRATIVE.