BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS TIBIAL INSERTS SZ 4, 9MM

    MDR report key: 19392095 · Received May 24, 2024

    Report

    Report Number
    1038671-2024-01403
    Event Type
    Injury
    Date Received
    May 24, 2024
    Date of Event
    September 27, 2023
    Report Date
    October 10, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862048387
    PMA / PMN Number
    K933610
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT DEVICES: 2012977 234-03-04 - OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 4. 2859734 204-04-43 - TRAPEZOID TIBIAL TRAY SZ 4F/3T. 2877683 200-02-29 - THREE PEG PATELLA 29MM. THE PRODUCT ASSOCIATED WITH THIS REPORT EVENT IS WITHIN THE SCOPE OF RECALL Z-0019-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORT EVENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OF CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILLED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    H6: CORRECTED THE FOLLOWING: HEALTH EFFECT - CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS THE REASON THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, RANGE OF MOTION, AND LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. HOWEVER, THE REPORTED PROSTHESIS WEAR, RANGE OF MOTION, AND LOOSENING COULD NOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF USER OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO IMAGES, RADIOGRAPHS, OR RELEVANT CLINICAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 115 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS, ASEPTIC LOOSENING, KNEE PAIN, SWELLING, JOINT EFFUSION, BONE LOSS, DIFFICULTY WALKING, AND LIMITED RANGE OF MOTION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2333308 PS TIBIAL INSERTS SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862048387

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H