BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM

    MDR report key: 14880496 · Received June 30, 2022

    Report

    Report Number
    1038671-2022-00749
    Event Type
    Injury
    Date Received
    June 30, 2022
    Date of Event
    June 4, 2022
    Report Date
    September 15, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173638
    PMA / PMN Number
    K110547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL IMPLANT DATE UNKNOWN. DEVICE NOT RETURNING AS HOSPITAL HAS SENT IT TO PATHOLOGY.

    Additional Manufacturer Narrative · 0

    H7: Z-0021-2022.

    Additional Manufacturer Narrative · 0

    H2: BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF SURGICAL REVISION FOR INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. H7: Z-2112 THRU 2133-2021.

    Description of Event or Problem · 0

    AS REPORTED, POST OP THE INITIAL LEFT TKA, THIS (B)(6) MALE PATIENT WAS REVISED DUE TO INFECTION, WASH OUT AND REIMPLANTATION OF POLY INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IS THE REPORTED EVENT ASSOCIATED WITH REVISION OF EXACTECH IMPLANTS? YES. WHAT SIDE WAS EFFECTED? LEFT. DO YOU KNOW THE INITIAL IMPLANT DATE (INDEX SURGERY DATE)? UNKNOWN. WAS THE PATIENT REVISED TO EXACTECH DEVICES? YES. IS THE REPORTED EVENT RELATED TO THE BREAKAGE OF A DEVICE? NO. THE REPORTED EVENT DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. PATIENT¿S RELEVANT MEDICAL HISTORY AND COMORBIDITIES ARE UNKNOWN. DOES THIS PATIENT HAVE OTHER IMPLANTS? UNKNOWN. PLEASE PROVIDE ANY OTHER IMPLANTS THAT THE PATIENT HAS. UNKNOWN. ADDITIONAL COMMENTS: SIMPLE INFECTION RELATION WASH OUT AND REIMPLANTATION OF POLY INSERT. THE PRODUCT(S) AVAILABLE FOR RETURN. UNABLE TO OBTAIN PHOTOS OR X-RAYS. DATE OF BIRTH: (B)(6) MALE. 510K: K110547.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2206912 LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, JWH EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM UNK 10885862173638

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention