BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CR INS STD SZ 5, 13MM

    MDR report key: 17958175 · Received October 18, 2023

    Report

    Report Number
    1038671-2023-02552
    Event Type
    Injury
    Date Received
    October 18, 2023
    Date of Event
    May 10, 2022
    Report Date
    November 26, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862306593
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 6110294, 02-012-60-1440 - TRU STEM EXT 14MM X 40MM. 6721808, 02-020-13-0250 - TRULIANT CR CEM FEM CR CEM LEFT SZ 5. 6818540, 02-022-45-5050 - TRULIANT TIB FIT TRAY CEM SZ 5F / 5T. 6870038, 200-02-38 - THREE PEG PATELLA 38MM. 6827049, 204-70-00 - TIBIAL STEM EXT. SCREW. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED CANNOT BE DETERMINED FROM THE AVAILABLE INFORMATION BUT MAY HAVE BEEN REPORTED AT THIS LATER TIME DUE TO INCLUSION OF ONE OF THE IMPLANTED DEVICES IN THE PACKAGING RECALL. BASED ON LENGTH OF IMPLANTATION, THE REASON FOR REVISION APPEARS UNLIKELY TO BE SECONDARY TO PROSTHESIS WEAR. HOWEVER, THE REPORTED PROSTHESIS WEAR/FAILURE, AND LOSS OF RANGE OF MOTION COULD NOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF USER, OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS NO IMAGES OR RADIOGRAPHS WERE PROVIDED, RELEVANT CLINICAL INFORMATION WAS NOT PROVIDED, AND THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. 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

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2021. OVER THE NEXT SEVERAL MONTHS, THE PATIENT UNDERWENT PHYSICAL THERAPY SESSIONS AND FOLLOW UP APPOINTMENTS WITH THE SURGEON, AS WELL AS INJECTIONS TO HIS LEFT KNEE. APPROXIMATELY 10 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022 TO REMOVE THE POLYETHYLENE, CAUSING THE INJURIES AND DAMAGES COMPLAINED OF. 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. REVISION OP REPORT ON (B)(6) 2022. DIAGNOSIS: PAINFUL LEFT TOTAL KNEE, POLYETHYLENE WEAR. AT THE TIME OF SURGERY THERE WAS SOME MINOR WEAR OF THE POLYETHYLENE ON BOTH THE LATERAL AND MEDIAL TIBIAL SURFACES WITH SOME MORE SIGNIFICANT WEAR ALONG THE POSTERIOR MEDIAL CORNER OF THE POLYETHYLENE. THE FEMORAL AND TIBIAL COMPONENTS WERE INTACT. THE 13MM POLYETHYLENE WAS EXCHANGED FOR A NEW 15 MM POLYETHYLENE AND THE KNEE SHOWED EXCELLENT RANGE OF MOTION AND STABILITY. THE PATIENT WAS ALSO NOTED TO HAVE HEAVY SCAR TISSUE THROUGHOUT THE JOINT CAPSULE. THE SCAR TISSUE WAS DEBRIDED ALONG THE SUPRAPATELLAR POUCH AND MEDIAL AND LATERAL GUTTERS. THE PATIENT WAS TAKEN TO RECOVERY ROOM IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619174 TRULIANT TIB IMP CR INS STD SZ 5, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862306593

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention