BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC

    MDR report key: 16845392 · Received May 1, 2023

    Report

    Report Number
    1038671-2023-00874
    Event Type
    Injury
    Date Received
    May 1, 2023
    Date of Event
    March 27, 2023
    Report Date
    February 24, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862144331
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: THE REVISIONS REPORTED WERE LIKELY THE RESULT OF PROSTHESIS WEAR AS STATED IN THE EXPERIENCE REPORT. BASED ON THE IMAGES PROVIDED OF THE REVISED INSERTS, THERE APPEARS TO BE SOME ISOLATED DEFORMATION AND/OR PITTING ON THE ARTICULAR SURFACE OF THE TIBIAL INSERT IN FIGURE 2 AND POSSIBLE CLEANING DAMAGE ON THE INSERT SHOWN IN FIGURE 1. HOWEVER, THE NATURE AND EXTENT OF THE DAMAGE CANNOT BE DETERMINED BASED ON THE SOLELY PROVIDED IMAGES. AN ADDITIONAL CONTRIBUTING FACTOR TO THE REVISIONS MAY HAVE BEEN INCLUSION OF THE IMPLANTED POLYETHYLENE COMPONENTS IN THE PACKAGING RECALL.

    Additional Manufacturer Narrative · 0

    D2B: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. D10: CONCOMITANTS: 6147190 02-010-04-0315 - LOGIC CR FEMORAL POR, RIGHT, SZ 1.5, 3961908 02-012-45-1515 - LGC TIBIAL FIT TRAY CEM SZ 1.5F / 1.5T, 6494607 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK, 6557683 201-78-81 - 3 TROCAR, MOD. HEX 2PK, 6557684 201-78-81 - 3 TROCAR, MOD. HEX 2PK, 6557705 201-78-81 - 3 TROCAR, MOD. HEX 2PK, 6557707 201-78-81 - 3 TROCAR, MOD. HEX 2PK, S048809 521-78-23 - THREADED PIN SIZE 2.3 COLLARED, S048826 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 66 YO FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2020, WAS REVISED ON (B)(6) 2023, APPROXIMATELY 2 YEARS 8 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO POLY WEAR. THE INSERT WAS REPLACED. THERE WAS NO SURGICAL DELAYS PROLONGATION DURING THE PROCEDURE. THE EVENT IS NOT RELATED TO A DEVICE BREAKAGE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS ANTICIPATED DUE TO THE HOSPITAL DISPOSED OF THE IMPLANTS. DEVICE IMAGE PROVIDED. X-RAYS WERE UNABLE TO BE OBTAINED. NO FURTHER INFORMATION. EVENT ASSOCIATED WITH REVISION OF EXACTECH IMPLANTS? YES, BILATERAL INITIAL IMPLANT DATE: ON (B)(6) 2002 (B)(6), ON (B)(6) 2021 (B)(6). PATIENT REVISED TO EXACTECH DEVICES? YES. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. PHOTOS ATTACHED. UNABLE TO OBTAIN X-RAYS. PRODUCT NOT RETURNING: DISPOSED BY HOSPITAL. 6077567 02-012-47-1509 - LOGIC TIBIAL INSERT STD, SZ 1.5, 9 MM. SERIAL NUMBER: (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K111400. CONCOMITANTS: 6147190 02-010-04-0315 - LOGIC CR FEMORAL POR, RIGHT, SZ 1.5, 3961908 02-012-45-1515 - LGC TIBIAL FIT TRAY CEM SZ 1.5F / 1.5T, 6494607 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK, 6557683 201-78-81 - 3 TROCAR, MOD. HEX 2PK, 6557684 201-78-81 - 3 TROCAR, MOD. HEX 2PK, 6557705 201-78-81 - 3 TROCAR, MOD. HEX 2PK, 6557707 201-78-81 - 3 TROCAR, MOD. HEX 2PK, 329258 203-90-01 - 11-2624 POWERPRO SAWBLADE, 5X098 203-90-21 - (2716) HALL PWR PRO/VERS PWR PLUS 90X13/21X1.19MM, S048809 521-78-23 - THREADED PIN SIZE 2.3 COLLARED, S048826 521-78-23 - THREADED PIN SIZE 2.3 COLLARED, 1000320002 A10012 - GPS IMPLANT KIT V2. REFER TO CASE: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832710 LOGIC SEE H10 JWH EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 1.5, 9 MM UNK 10885862144331

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention