BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 20428259 · Received October 11, 2024

    Report

    Report Number
    1038671-2024-03938
    Event Type
    Injury
    Date Received
    October 11, 2024
    Date of Event
    October 30, 2019
    Report Date
    October 11, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    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 (MDL NO. 3044) (NGG) (MMH) PATIENT ID: LINDA HART RK REFER TO CASE (B)(4). FOR LK CASE NO: (B)(4) IT WAS REPORTED THAT APPROXIMATELY 108 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS, METALLOSIS, INSTABILITY, LIMITED MOBILITY, SWELLING AND PAIN. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. FEMORAL COMPONENT (FM: LOOSENING) PRODUCT: 9999 510K: N/A UDI: N/A PRODUCT CODE: JWH X-RAY: NO OPERATIVE NOTES: NO CONCOMITANTS: UNKNOWN TIBIA INSERT (FM: PROSTHESIS WEAR) PRODUCT: 9999 510K: N/A UDI: N/A PRODUCT CODE: JWH X-RAY: NO OPERATIVE NOTES: NO CONCOMITANTS: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335213 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R