BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 20926056 · Received December 13, 2024

    Report

    Report Number
    1038671-2024-04821
    Event Type
    Injury
    Date Received
    December 13, 2024
    Date of Event
    December 6, 2024
    Report Date
    April 4, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: A10012 - GPS IMPLANT KIT V2 08013018039 203-96-42 - (11-3671) STRYKER SYS 6 90X13/21X1.19 258582 02-010-04-0220 - LOGIC CR FEMORAL POR, LEFT, SZ 2 3857559 203-96-40 - (11-3661) STRYKER SYS 6 90X25X1.27 52042 02-012-47-2009 - LOGIC CR TIB INSERT STD, SZ 2, 9MM 5230803 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T 5303860 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 5375836 201-78-81 - 3 TROCAR, MOD. HEX 2PK 5408004 201-78-81 - 3 TROCAR, MOD. HEX 2PK 5408018 200-02-35 - THREE PEG PATELLA 35MM 5544474 201-78-81 - 3 TROCAR, MOD. HEX 2PK 5545219 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK 5719597 521-78-36 - THREADED PIN SIZE 5.1 COLLARLESS S004841 521-78-23 - THREADED PIN SIZE 2.3 COLLARED S005400.

    Additional Manufacturer Narrative · 0

    "THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REPORTED REVISION CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL, WEAR, LOOSENING, INFECTION, FRACTURE, INSTABILITY, OR PATIENT RELATED FACTORS. 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, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTION WAS CORRECTED: G6. G6: THE REPORT TYPE WAS INCORRECTLY SELECTED AS A 5-DAY REPORT IN THE INITIAL SUBMISSION. THIS HAS BEEN CORRECTED TO A 30-DAY REPORT TO ALIGN WITH THE REPORTING REQUIREMENTS IN CFR 803.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 76 YO FEMALE PATIENT, INITIAL LEFT KNEE IMPLANTED IN (B)(6) 2019, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 5 YEARS 11 MONTHS POST THE INITIAL PROCEDURE. REASON FOR THE REVISION IS UNKNOWN. ALL DEVICES WERE REMOVED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE AVAILABLE, THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE DISCARDED. NO IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1923633 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention SEE H11