BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 4 9MM

    MDR report key: 17256745 · Received July 5, 2023

    Report

    Report Number
    1038671-2023-01533
    Event Type
    Injury
    Date Received
    July 5, 2023
    Date of Event
    June 12, 2023
    Report Date
    October 9, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304438
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANTS: 5060206 02-022-45-4030 - TRULIANT TIB FIT TRAY CEM SZ 4F / 3T 5236205 02-020-11-0340 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 4 5293859 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT 5320026 02-012-60-1425 - TRU STEM EXT 14MM X 25MM 5330961 204-70-00 - TIBIAL STEM EXT. SCREW.

    Additional Manufacturer Narrative · 0

    H6: CORRECTED THE FOLLOWING: HEALTH EFFECT - CLINICAL CODE, HEALTH EFFECT - IMPACT CODE, MEDICAL DEVICE PROBLEM CODE, COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS MANUFACTURER NARRATIVE UPDATED: THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. HOWEVER, THE REPORTED PROSTHESIS WEAR 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

    AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT UNDERWENT RIGHT KNEE REPLACEMENT ON (B)(6) 2018. THEY ARE SCHEDULED TO UNDERGO RIGHT KNEE REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 5 YEARS 2 MONTHS AFTER THEIR INITIAL PROCEDURE. PATIENT CLAIMS TO HAVE SUFFERED AND CONTINUES TO SUFFER PERMANENT AND DEBILITATING INJURES AND DAMAGES, INCLUDING BUT NOT LIMITED TO SIGNIFICANT PAIN AND DISCOMFORT, SWELLING, LIMITED MOBILITY, INABILITY TO BEND OR KNEEL, GAIT IMPAIRMENT, 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
    989482 TRULIANT TIB IMP PS INSERT SZ 4 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. 02-022-35-4009 UNK 10885862304438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H10.