BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 3.5 11MM

    MDR report key: 19018749 · Received April 2, 2024

    Report

    Report Number
    1038671-2024-00710
    Event Type
    Injury
    Date Received
    April 2, 2024
    Date of Event
    December 12, 2023
    Report Date
    December 27, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304360
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10. D10. CONCOMITANTS: 7248, 203-96-67 - FAN SAWBLADE EZ2213F.M63 90X22 1.27MM STRKR 5/6/7. 5673547, 02-020-12-0335 - TRULIANT PS POR FEM PS POR RIGHT SZ 3.5. 6030527, 02-022-55-3525 - TRULIANT POR TIB TRAY SIZE 3.5F/2.5T. 6118996, 201-78-89 - 3" DRILL BIT, MOD. HEX 2 PACK. 6557098, 200-02-32 - THREE PEG PATELLA 32MM. 6715429, 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK. S012816, 180-65-45 - ALTEON 6.5MM SCREW, 45MM. S034476, 180-65-45 - ALTEON 6.5MM SCREW, 45MM. S089300, 521-78-31 - THREADED PIN SIZE 2.6 COLLARLESS 2PK. S099112, 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D1, D2A, D2B, G3, G4, H6 THE FOLLOWING SECTIONS WERE CORRECTED: H6 MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, G THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND INSTABILITY 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 AND RADIOGRAPHS 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 VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A TOTAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2020 AND THEN APPROXIMATELY 3 YEARS 1 MONTH LATER EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023. REVISION OPERATIVE REPORT OF (B)(6) 2023- POSTOPERATIVE DIAGNOSIS: MECHANICAL FAILURE RIGHT TOTAL KNEE ARTHROPLASTY WITH INSTABILITY PROCEDURE PERFORMED: REVISION RIGHT TOTAL KNEE ARTHROPLASTY FEMORAL AND TIBIAL COMPONENTS. PATIENT REVISED TO COMPETITOR'S DEVICES. FINDINGS: NO CLINICAL EVIDENCE OF INFECTION, HISTOLOGICAL ANALYSIS DEMONSTRATED NO ACUTE INFLAMMATION, LIGAMENTOUS AND FLEXION INSTABILITY, PREDOMINANTLY LATERALLY, WELL FIXED FEMORAL, TIBIAL, AND PATELLAR COMPONENTS, POLY WEAR WITH GROSS INSTABILITY. THE PATIENT WAS AWAKENED AND SENT TO THE RECOVERY ROOM IN STABLE CONDITION. THERE WERE NO COMPLICATIONS. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. 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
    1665784 TRULIANT TIB IMP PS INSERT SZ 3.5 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862304360

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention SEE H10.