BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 1.5, 13MM

    MDR report key: 20337620 · Received September 30, 2024

    Report

    Report Number
    1038671-2024-03752
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    September 30, 2024
    Report Date
    May 9, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304018
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED CONCOMITANT IMPLANTS, UDI#, 510K #. CORRECT CONCOMITANTS: 6559109 02-020-11-0315 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 1.5. 6845105 02-022-45-1510 - TRULIANT TRAY, CEM SZ 1.5F/1T. 7057270 200-07-29 - ADVANCED PATELLA 29M 3 PEG IMPLANT. 6851997 201-78-82 - COLLAR FIXATION PIN 2PK 40MM, QUICK RELEASE. 6908324 201-78-89 - 3"" DRILL BIT, MOD. HEX 2 PACK. 6908332 201-78-89 - 3"" DRILL BIT, MOD. HEX 2 PACK.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6 (TYPE OF INVESTIGATION) THE FOLLOWING SECTIONS WERE CORRECTED: B3 H6 (HEALTH EFFECT - CLINICAL CODE, HEALTH EFFECT - IMPACT CODE) THE REASON FOR THE REPORTED EVENT CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE DUE TO PROSTHESIS WEAR AND/OR 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.

    Additional Manufacturer Narrative · 0

    CONCOMITANTS: (B)(6) 02-020-11-0345 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 4.5 (B)(6) 02-022-45-4535 - TRULIANT TIB FIT TRAY CEM SZ 4.5F/3.5T (B)(6) 02-012-60-1425 - TRU STEM EXT 14MM X 25MM (B)(6) 200-02-35 - THREE PEG PATELLA 35MM (B)(6) 204-70-00 - TIBIAL STEM EXT. SCREW. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0023-2022. HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    LEGAL CASE ¿ USA (MASTER CASE NO. (B)(4). IT WAS REPORTED THAT APPROXIMATELY 8 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, LATERAL JOINT PAIN, SYNOVITIS, SWELLING, INSTABILITY, OSTEOLYSIS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0023-2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35240 TRULIANT TIB IMP PS INSERT SZ 1.5, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862304018

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R