BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 20428692 · Received October 11, 2024

    Report

    Report Number
    1038671-2024-03939
    Event Type
    Injury
    Date Received
    October 11, 2024
    Date of Event
    January 20, 2012
    Report Date
    October 11, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    LEGAL CASE-USA: PATIENT ID: (B)(6). REFER TO (B)(4). AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2012. THE DEVICE HAS NOT BEEN EXPLANTED. THE PATIENT HAS SUFFERED AND CONTINUES TO SUFFER PERMANENT AND DEBILITATING INJURES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; AND BONE LOSS. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. INITIAL EBI SURGERY UNABLE TO BE LOCATED. PRODUCT INFORMATION: 02-012-35-2009 LOGIC TIBIA PS MOD INSRT SZ 2 9MM, (B)(6): SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510(K): K033883. RECALL: Z-0021-2022. AS DIRECTED BY QA MANAGEMENT: THIS LEGAL COMPLAINT FOR POLYETHYLENE ISSUES OCCURRED IN THE US. THE EVENT DID NOT OCCUR IN, NOR IS IT REPORTABLE FOR AUSTRALIA, BRAZIL, CANADA, EEA/EU, JAPAN, TAIWAN, OR GREAT BRITAIN, EXCLUDING NORTHERN IRELAND. THEREFORE, ONLY THE US REPORTABILITY DETERMINATION WILL BE ASSESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343065 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown