BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS TIBIAL INSERTS SZ 2, 13MM

    MDR report key: 16395802 · Received February 17, 2023

    Report

    Report Number
    1038671-2023-00187
    Event Type
    Injury
    Date Received
    February 17, 2023
    Date of Event
    January 27, 2023
    Report Date
    January 30, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862048240
    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

    ADDITIONAL MANUFACTURER NARRATIVE: PENDING EVALUATION.

    Additional Manufacturer Narrative · 0

    H10. RELATED: MFR #1038671-2024-02490 REPORT 2 OF 2. H11. ADDITIONAL MANUFACTURER NARRATIVE- ADDITIONAL INFORMATION ADDED. REPORT 1 OF 2. D10. CONCOMITANTS: 200-02-32 - THREE PEG PATELLA 32MM, 2543858. 204-01-02 - PS CEMENTED FEMORAL SZ 2, 8221698. 204-04-22 - TRAPEZOID TIBIAL TRAY SZ 1F/2T, 2F/2T, 1200696. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2024-02490. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6 THE FOLLOWING SECTIONS WERE CORRECTED: B1 B2 G2 H6 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. ADDITIONALLY, THESE DEVICES APPEAR TO HAVE BEEN IMPLANTED FOR OVER TEN YEARS PRIOR TO THE REPORTED EVENT. 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. THE PRODUCT ASSOCIATED WITH THE REPORTED 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 REPORTED EVENT. 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 IS BEING REVISED TO A HINGED KNEE. IN RECENT MONTHS, PATIENT HAS REPORTED INCREASE IN KNEE PAIN. SURGEON THOUGHT IT MIGHT BE A CHRONIC INFECTION ISSUE BUT BELIEVES THIS IS A POLY WEAR ISSUE AS IMAGINE SHOWS ASYMMETRY IN THE POLY.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT KNEE REVISION AND THEN EXPERIENCED A SECOND REVISION SURGICAL PROCEDURE APPROXIMATELY 10 YEARS AFTER REVISION SURGERY. 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 WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166888 PS TIBIAL INSERTS SZ 2, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK UNK 10885862048240

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H11.