BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEDGE PLASMA X/O SZ 4

    MDR report key: 11992550 · Received June 14, 2021

    Report

    Report Number
    1038671-2021-00296
    Event Type
    Injury
    Date Received
    June 14, 2021
    Date of Event
    May 25, 2021
    Report Date
    July 8, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862250933
    PMA / PMN Number
    K140674
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS G3, G7, H2, H3 AND H6 HAVE BEEN UPDATED ACCORDINGLY. AS REPORTED, APPROXIMATELY 3 MONTHS POSTOP THE INITIAL RTHA, THIS 53 Y/O FEMALE PATIENT EXPERIENCED A PERI PROSTHETIC FRACTURE AND WAS REVISED TO MONOBLOC STEM. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION DUE TO FACILITY POLICY. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN, MANUFACTURING, OR PATIENT RELATED ISSUES. THE CAUSE OF THE BONE FRACTURE CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY IS RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS - BIOLOX DELTA FEMORAL HEAD 32MM OD, +3.5MM (CAT# 170-32-03 / SERIAL# (B)(4)). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY 3 MONTHS POSTOP THE INITIAL RTHA, THIS (B)(6) Y/O FEMALE PATIENT EXPERIENCED A PERI PROSTHETIC FRACTURE, AND WAS REVISED TO MONOBLOC STEM. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION DUE TO FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889555 WEDGE PLASMA X/O SZ 4 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. WEDGE PLASMA X/O SZ 4 UNK 10885862250933

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention| S