BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENDER SOLUTIONS ALL POLY PATELLA SIZE 0 8 MM THICKNESS

    MDR report key: 20796436 · Received November 27, 2024

    Report

    Report Number
    0002648920-2024-00363
    Event Type
    Injury
    Date Received
    November 27, 2024
    Report Date
    November 26, 2024
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    UDI-DI
    00889024189584
    PMA / PMN Number
    K173057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 00585204025 - STEM COLLAR 25 MM O.D. FOR USE WITH 16 MM OR SMALLER DIAMETER SEGMENTAL STEMS - 64243673 5036964 - HERAEUS MEDICAL CEMENT W/GENT HIGH VISCOCITY - (B)(6) 183302 - VNGD SSK PSC INTLK FMRL 60 RT - (B)(6) 183824 - VNGD SSKPSC TIB BRG S 14X63/67 - (B)(6) 185201 - BMT 360 TIB TRAY 63MM - (B)(6) 148162 - BMT GB KNEE STM 12X80 - (B)(6) 130615 - INTRAMEDULLARY PLUG XL - (B)(6). NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. OFFICE NOTES POST-SURGERY STATE PATIENT STILL HAS PAIN, SWELLING AND RANGE OF MOTION ISSUES. PATIENT IS ALSO EXPERIENCING KNEE WEAKNESS WHICH HAS LIMITED HER FUNCTIONAL MOBILITY. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE SURGERY AND APPROXIMATELY 3 MONTHS POST-OP, THE PATIENT WAS DIAGNOSED WITH PATELLAR TENDONITIS AND RECEIVED A STEROID INJECTION. THE PATIENT CONTINUED TO HAVE ONGOING ISSUES WITH PAIN, SWELLING, QUADRICEP WEAKNESS/ATROPHY, BALANCE DEFICITS, AND LIMITED RANGE OF MOTION. ADDITIONAL COURSES OF PHYSICAL THERAPY WERE PRESCRIBED WITHOUT RESOLUTION. THE PATIENT DOES NOT WANT TO UNDERGO ANOTHER REVISION AND HAS CONTINUED TO SEEK HELP FOR ONGOING SYMPTOMS. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2367285 GENDER SOLUTIONS ALL POLY PATELLA SIZE 0 8 MM THICKNESS PROSTHESIS, KNEE JWH ZIMMER MANUFACTURING B.V. N/A 64212622 00889024189584

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SEE H11.