BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 4 13MM

    MDR report key: 20131348 · Received September 3, 2024

    Report

    Report Number
    1038671-2024-03246
    Event Type
    Injury
    Date Received
    September 3, 2024
    Date of Event
    November 24, 2023
    Report Date
    September 3, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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

    COMPLAINT REVIEW NOTE- (B)(6) 2024, (B)(6), RN- OP REPORT- FAILED RIGHT KNEE SECONDARY TO MASSIVE OSTEOLYSIS/ BMI 38- LOOSE TIBIA AND FEMORAL COMPONENTS- TO ENG.LOI /FDA REPORTABLE/ FM LOOSENING. LEGAL CASE-USA. PATIENT ID: (B)(6). THIS PATIENT IS VERIFIED RIGHT KNEE ON (B)(6) 2010 AT (B)(6) CLINIC. RIGHT KNEE REVISION (B)(6) 2023 WITH DR (B)(6) (OP REPORT ATTACHED). NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. EBI INITIAL SURGERY UNABLE TO BE FOUND. HISTORICAL RECORD & SMARTSOLVE SEARCHED FOR SN/PATIENT NAME WITH NO RESULTS. OPERATIVE REPORT FROM REVISION SURGERY ATTACHED. NO FURTHER INFORMATION. PRODUCT INFORMATION 02-012-35-4013 LOGIC TIBIA PS MOD INSRT SZ 4 13MM 1683992; SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510(K): K033883.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918473 LOGIC TIBIA PS MOD INSRT SZ 4 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention| H UNK.