BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 3.5 9MM

    MDR report key: 16733209 · Received April 13, 2023

    Report

    Report Number
    1038671-2023-00674
    Event Type
    Injury
    Date Received
    April 13, 2023
    Date of Event
    July 12, 2022
    Report Date
    December 26, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001849
    PMA / PMN Number
    K093360
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANTS: (B)(4) 02-010-01-0335 - LOGIC FEMORAL PS CEM RIGHT SZ 3.5; (B)(4) 02-012-45-3535 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T; (B)(4) 1510-S - CEMEX SYSTEM FAST 70 GM; (B)(4) 200-02-35 - THREE PEG PATELLA 35MM; (B)(4) ASA0030 - STERILE DISPOSABLE CONTAINERS. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    1038671-2024-05007 1038671-2024-05008 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6 (COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS) THE FOLLOWING SECTIONS WERE CORRECTED: H6 (HEALTH EFFECT - CLINICAL CODE, HEALTH EFFECT- IMPACT CODE, MEDICAL DEVICE PROBLEM CODE) THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND FEMORAL LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    LEGAL CASE - USA. PATIENT ID: (B)(6). PER A REPORT FROM THE LEGAL DEPARTMENT, THE PATIENT HAD AN INITIAL RIGHT KNEE REPLACEMENT ON (B)(6) 2013. ON (B)(6) 2022, APPROXIMATELY 9 YEARS AND 4 MONTHS LATER, THE PATIENT HAD RIGHT KNEE REVISION (OP REPORT ATTACHED). DIAGNOSIS DURING THE REVISION WAS TO ASCEPTIC LOOSENING. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. EBI INITIAL SURGERY ATTACHED. (B)(4), 02-012-35-3509 - LOGIC TIBIA PS MOD INSRT SZ 3.5 9MM. SERIAL NUMBER (B)(4) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K093360. CONCOMITANTS: (B)(4) 02-010-01-0335 - LOGIC FEMORAL PS CEM RIGHT SZ 3.5. (B)(4) 02-012-45-3535 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T. (B)(4) 1510-S - CEMEX SYSTEM FAST 70 GM. (B)(4) 200-02-35 - THREE PEG PATELLA 35MM. (B)(4) ASA0030 - STERILE DISPOSABLE CONTAINERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095197 LOGIC TIBIA PS MOD INSRT SZ 3.5 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3.5 9MM UNK 10885862001849

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention SEE H10.