BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN FEMORAL COMPONENT

    MDR report key: 22777713 · Received August 11, 2025

    Report

    Report Number
    0001822565-2025-02870
    Event Type
    Injury
    Date Received
    August 11, 2025
    Report Date
    August 11, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). B3: EVENT DATE - ARTICLE WAS PUBLISHED ON AN UNKNOWN DATE IN MAY 2025. D10: UNKNOWN, ARTICULAR SURFACE, UNKNOWN LOT. UNKNOWN, TIBIAL COMPONENT, UNKNOWN LOT. G2: LITERATURE: GUNDA, B., GOLDBERG, L. ALBAN, A. STRECKER, S. MCCRACKEN, C., CARANGELO, R. J., WITMER, D. (2025) THE EFFECT OF THE DESIGN OF POLYETHYLENE INSERTS IN TOTAL KNEE ARTHROPLASTY ON PATIENT REPORTED OUTCOMES. JOURNAL OF THE AAOS GLOBAL RESEARCH & REVIEWS. 9(5)1-6. HTTPS://DOI.ORG/10.5435/JAAOSGLOBAL-D-25-00075. H6: COMPONENT CODE - PROPOSED CODE IS MECHANICAL (G04) - FEMUR. THE EVENT IS NOT CONFIRMED. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. 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. DESPITE PROPHYLAXIS, DVTS CAN STILL DEVELOP WHICH CAN THEN BREAK FREE WITHIN THE VESSEL AND OCCLUDE OR BLOCK THE BLOOD FLOW IN THE LUNGS, KNOWN AS A PULMONARY EMBOLISM (PE). AS THE COMPLAINT INDICATED, A POST-OPERATIVE COMPLICATION OCCURRED, AND MEDICAL INTERVENTION WAS REQUIRED FOR TREATMENT. REPORTED EVENT IS NOT RELATED TO DEVICE THEREFORE, A COMPATIBILITY REVIEW IS NOT APPLICABLE. NO FURTHER ACTIONS WILL BE INITIATED AS A RESULT OF REPORTED EVENT. ROOT CAUSE OF THE REPORTED EVENT IS NOT DEVICE RELATED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. SHOW LESS.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM A JOURNAL ARTICLE THAT ONE IN SIX PATIENTS WERE READMITTED WITHIN 30 DAYS AFTER THE INITIAL KNEE ARTHROPLASTY DUE TO PULMONARY EMBOLISM. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2183790 UNKNOWN FEMORAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11.