BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 20989035 · Received December 20, 2024

    Report

    Report Number
    1038671-2024-04971
    Event Type
    Injury
    Date Received
    December 20, 2024
    Date of Event
    December 16, 2024
    Report Date
    April 7, 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

    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 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

    D10: CONCOMITANTS: 10041220019, (B)(6) - GPS IMPLANT KIT V2, (B)(6), 02-012-45-5040 - LGC TIBIAL FIT TRAY CEM SZ 5F / 4T, (B)(6), 02-012-51-5011 - LOGIC TIB INSERT IMPL CRC, SZ 5, 11MM, (B)(6), 200-02-38 - THREE PEG PATELLA 38MM, (B)(6), 02-010-04-0250 - LOGIC CR FEMORAL POR, LEFT, SZ 5, (B)(6), 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK, (B)(6), 201-78-81 - 3 TROCAR, MOD. HEX 2PK, (B)(6), 521-78-23 - THREADED PIN SIZE 2.3 COLLARED, (B)(6), 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS, (B)(6), 521-78-23 - THREADED PIN SIZE 2.3 COLLARED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 53 YO MALE PATIENT, WHO HAD AN INITIAL LEFT KNEE IMPLANTED ON (B)(6)2022, AND HAD A REVISION DONE ON (B)(6) 2023, UNDERWENT A SECOND REVISION ON (B)(6) 2024, APPROXIMATELY 2 YEARS 10 MONTHS POST ON (B)(6) 2023 PROCEDURE. THE REASON FOR THE REVISION IS UNKNOWN. EVERYTHING WAS REMOVED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE OBTAINED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE DISPOSED AT THE HOSPITAL. NO DEVICE IMAGES WERE OBTAINED. NO FURTHER INFORMATION. ON (B)(6) 2023, REVISION REPORTED UNDER MDR# 1038671-2024-00035.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2154524 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Hospitalization| R SEE H11.