BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN METAL COMPONENT

    MDR report key: 22411391 · Received July 7, 2025

    Report

    Report Number
    1038671-2025-02427
    Event Type
    Injury
    Date Received
    July 7, 2025
    Date of Event
    December 20, 2024
    Report Date
    November 5, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6, H11. THE FOLLOWING SECTIONS WERE CORRECTED: H6. H11: THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. A REVIEW OF MANUFACTURING DATA WAS PERFORMED, AND NO DISCREPANCIES WERE FOUND. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED; HOWEVER, WAS LIKELY DUE TO THE REPORTED LOOSENING, PROSTHESIS WEAR, OR DUE TO THE INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. FAILURE OF THE CEMENT USED TO SECURE THE FEMORAL AND/OR TIBIAL COMPONENT TO THE RESPECTIVE BONE, MAY HAVE LEAD TO LOOSENING AT THE CEMENT-IMPLANT AND/OR CEMENT-BONE INTERFACE; HOWEVER, THIS CANNOT BE CONFIRMED. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, EXCESSIVE POSTERIOR SLOPE, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. 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: (B)(6), 200-04-22 - (DISC) CEMENTED FINNED T IB. TRA SZ 2F/2T. (B)(6), 234-02-02 - (DISC) OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 2, (B)(6), 21-0901-19L-V1 - HALL LPI90X13/21X1.19 NUEVA (V193-119-90). (B)(6), 21-0901-19Y-V1 - STRYKER LPI S7/6/5/4 H.SIERRA 90*13/21*1,19. H3: THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 8 YEARS 6 MONTHS POST INITIAL OPERATION. PATIENT WAS EXPERIENCING PREMATURE WEAR AND A FRACTURE OF THE POLYETHYLENE WITH MECHANICAL LOOSENING OF THE IMPLANT SECONDARY TO MASSIVE OSTEOLYSIS. PATIENT WAS REVISED TO A COMPETITORS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950583 UNKNOWN METAL COMPONENT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization SEE H11