BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC

    MDR report key: 16591710 · Received March 22, 2023

    Report

    Report Number
    1038671-2023-00488
    Event Type
    Injury
    Date Received
    March 22, 2023
    Date of Event
    February 27, 2023
    Report Date
    August 15, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862159243
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PROCODE: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. CONCOMITANT MEDICAL PRODUCTS: CONCOMITANTS: 4958235 02-010-03-0235 - LOGIC CR FEMORAL CEM, LEFT, SZ 3.5, 5611369 02-012-45-3535 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T, 6331679 200-02-38 - THREE PEG PATELLA 38MM, 5972492 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK, 6056389 201-78-81 - 3 TROCAR, MOD. HEX 2PK, 6170359 201-78-81 - 3 TROCAR, MOD. HEX 2PK, 6573572 201-78-81 - 3 TROCAR, MOD. HEX 2PK, 5315765 521-78-23 - THREADED PIN SIZE 2.3 COLLARED, S003182 521-78-23 - THREADED PIN SIZE 2.3 COLLARED, S038766 521-78-36 - THREADED PIN SIZE 5.1 COLLARLESS. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED, BUT MAY BE DUE TO PROSTHESIS WEAR AS REPORTED OR INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. A CONTRIBUTING FACTOR TO THE REPORTED WEAR MAY HAVE BEEN DUE TO THE REVISED TIBIAL INSERT HAVING BEEN PACKAGED IN A NON-CONFORMING BAG FOR FIVE YEARS. HOWEVER, THE REPORTED PROSTHESIS WEAR COULD NOT BE CONFIRMED AS NO IMAGES OR RADIOGRAPHS WERE PROVIDED AND THE DEVICES WERE NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 77 YO MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2020, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 2 YEARS 5 MONTHS POST THE INITIAL PROCEDURE DUE TO POLY WEAR. THE INSERT WAS REPLACED. THERE WERE NO SURGICAL DELAYS REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR RETURN AS IT WAS DISPOSED OF BY THE HOSPITAL..

    Description of Event or Problem · 0

    10 DAYS FOLLOWING INITIAL PROCEDURE THE PATIENT WAS DISCHARGED AND UNDERWENT PHYSIOTHERAPY. THE PATIENT CONTINUED TO HAVE PAIN & SWELLING. DURING THE REVISION, A NEW OPTETRAK CRC INSERT WAS USED. 2 WEEKS AND 3 DAYS FOLLOWING THE REVISION PROCEDURE, THERE WERE NO POSTOPERATIVE COMPLICATIONS. (B)(6) 2023 THE PATIENT WAS REFERRED TO PHYSIOTHERAPY. THE PATIENT UNDERWENT 5 SESSIONS FOR PHYSIOTHERAPY & IS STILL HEALING DUE TO RECENT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496114 LOGIC SEE H10 JWH EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 3.5, 9 MM UNK 10885862159243

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention