BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS TIBIAL INSERTS SZ 2, 11MM

    MDR report key: 16395758 · Received February 17, 2023

    Report

    Report Number
    1038671-2023-00186
    Event Type
    Injury
    Date Received
    February 17, 2023
    Date of Event
    January 3, 2013
    Report Date
    January 27, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862048233
    PMA / PMN Number
    K933610
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION.

    Additional Manufacturer Narrative · 0

    H10. RELATED: MFR#1038671-2024-02484 REPORT 2 OF 2. H11. ADDITIONAL MANUFACTURER NARRATIVE- ADDITIONAL INFORMATION ADDED. REPORT 1 OF 2. D10. CONCOMITANTS: 200-02-32 - THREE PEG PATELLA 32MM, 1226926. 204-01-02 - PS CEMENTED FEMORAL SZ 2, 8221698. 204-04-22 - TRAPEZOID TIBIAL TRAY SZ 1F/2T, 2F/2T, 1200696. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A4, & B7 THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. H6. INVESTIGATION -BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: D1, H6 MDR SECTION CODES UPDATED/CORRECTED: B, E. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE LEGAL DEPARTMENT THAT THIS FEMALE PATIENT'S PS KNEE WAS REVISED 5 YEARS POST OP INITIAL SURGERY. REVISION WAS TO CHANGE THE PATELLA AND ADD A THICKER INSERT.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT KNEE ARTHROPLASTY AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE APPROXIMATELY 4 YEARS, 8 MONTHS AFTER INITIAL IMPLANT FOR THE TIBIAL INSERT COMPONENT. THE PATIENT EXPERIENCED DAILY PAIN AND DISCOMFORT IN HER RIGHT KNEE, WHICH HAS LIMITED HER ACTIVITIES OF DAILY LIVING AND IMPACTED HER QUALIFY OF LIFE. PATIENT HAS SUFFERED DEBILITATING INJURIES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, PAIN AND DISCOMFORT; SWELLING; GAIT IMPAIRMENT; POOR BALANCE; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS; BONE DAMAGE; AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGOING MEDICAL CARE. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173808 PS TIBIAL INSERTS SZ 2, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK UNK 10885862048233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention SEE H11.