BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 3, 11MM

    MDR report key: 16463668 · Received March 1, 2023

    Report

    Report Number
    1038671-2023-00313
    Event Type
    Injury
    Date Received
    March 1, 2023
    Date of Event
    April 6, 2018
    Report Date
    November 20, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174352
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: PENDING EVALUATION. CONCOMITANT MEDICAL DEVICE(S): 5242937, 02-010-04-0330 - LOGIC CR FEMORAL POR, RIGHT, SZ 3; 4984788, 02-012-45-3020 - LGC TIBIAL FIT TRAY CEM SZ 3F / 2T; 4954612, 200-02-32 - THREE PEG PATELLA 32MM; 5269011, 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK; 4950786, 201-78-82 - COLLAR FIXATION PIN 2PK 40MM, QUICK RELEASE.

    Additional Manufacturer Narrative · 0

    1038671-2024-04447 A2: ADDED THE FOLLOWING: DATE OF BIRTH. A3: ADDED THE FOLLOWING: GENDER. B1: CORRECTED THE FOLLOWING: TYPE OF REPORT (CHECK ALL THAT APPLY). B2: CORRECTED THE FOLLOWING: OUTCOMES ATTRIBUTED TO ADVERSE EVENT (CHECK ALL THAT APPLY). D6B: ADDED THE FOLLOWING: IF EXPLANTED, GIVE DATE. G1: CORRECTED THE FOLLOWING: REPORTING CONTACT FIRST NAME, REPORTING CONTACT LAST NAME, REPORTING CONTACT FACILITY NAME, REPORTING CONTACT ADDRESS LINE 1, REPORTING CONTACT US CITY, REPORTING CONTACT STATE (SELECT FROM FDA APPROVED LIST), REPORTING CONTACT US ZIP CODE(55555) OR (55555-4444) OR FOREIGN POSTAL, REPORTING CONTACT COUNTRY (SELECT FROM FDA APPROVED LIST). H6: CORRECTED THE FOLLOWING: HEALTH EFFECT - CLINICAL CODE, COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND FEMORAL LOOSENING. THE REPORTED PROSTHESIS WEAR AND FEMORAL LOOSENING COULD NOT BE CONFIRMED. 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. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED BY THE LEGAL, OVER A PERIOD OF TIME, THE PATIENT'S RIGHT KNEE BEGAN TO SUFFER FROM SYMPTOMS ASSOCIATED WITH EXCESSIVE WEAR OF THE EXACTECH KNEE DEVICES, INCLUDING BUT NOT LIMITED TO PAIN AND LACK OF MOBILITY. AS A DIRECT AND PROXIMATE RESULT OF THE FAILURE OF THE EXACTECH DEVICES, PATIENT HAS BEEN REQUIRED TO UNDERGO SURGICAL REMOVAL OF THE EXACTECH DEVICES, AND NOW HAS COMPONENTS WITH DECREASED LONGEVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435404 LOGIC CR TIB INSERT STD, SZ 3, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK UNK 10885862174352

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Hospitalization| R SEE H10