BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 20407910 · Received October 9, 2024

    Report

    Report Number
    1038671-2024-03894
    Event Type
    Injury
    Date Received
    October 9, 2024
    Date of Event
    August 15, 2022
    Report Date
    October 9, 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 - YOEL GLANZ LK REV RELATED CASE-2023-00007655 RK. IT WAS REPORTED VIA LEGAL NOTIFICATION, THAT PATIENT, WAS INITIALLY IMPLANTED WITH A RECALLED OPTETRAK LOGIC PS POLYETHYLENE TIBIAL INSERT (SERIAL #: (B)(6) IN HIS LEFT KNEE, ON (B)(6) 2009. ON (B)(6) 2022, PLAINTIFF UNDERWENT LEFT KNEE REVISION SURGERY, APPROXIMATELY 13 YEARS 5 MONTHS POST INITIAL PROCEDURE, DUE TO ACCELERATED AND PREVENTABLE WEAR OF THE OPTETRAK LOGIC PS POLYETHYLENE TIBIAL INSERT. AS A DIRECT, PROXIMATE, AND LEGAL CONSEQUENCE OF THE DEFECTIVE NATURE OF THE OPTETRAK DEVICES AS DESCRIBED HEREIN, PLAINTIFF HAS SUFFERED AND CONTINUES TO SUFFER PERMANENT AND DEBILITATING INJURIES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS; AND OTHER INJURIES WHICH ALL REQUIRE ONGOING MEDICAL CARE. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION. (B)(4) 02-012-35-2009 - LOGIC TIBIA PS MOD INSRT SZ 2 9MM ***SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K033883.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728479 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