BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 4.5 9MM

    MDR report key: 25027585 · Received April 29, 2026

    Report

    Report Number
    1038671-2026-00513
    Event Type
    Injury
    Date Received
    April 29, 2026
    Date of Event
    October 6, 2022
    Report Date
    April 29, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304520
    PMA / PMN Number
    K171045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: TRULIANT PS POR FEM PS POR RIGHT SZ 4.5(CAT#02-020-12-0345((B)(6)). TRULIANT TIB IMP PS INSERT SZ 4.5 9MM(CAT#02-022-35-4509((B)(6)). ADVANCED PATELLA 32MM 3 PEG IMPLANT(CAT#200-07-32((B)(6)). H10: MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2022-01346, 1038671-2026-00193. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/ TECHNIQUE. REVIEW OF THE NON-CONFORMING REPORTING DATABASE AND/OR DEVICE HISTORY RECORD CAN BE CONDUCTED TO LOOK FOR MANUFACTURING-RELATED ISSUES INCLUDING BUT NOT LIMITED TO DIMENSIONAL NON-CONFORMITIES OR ISSUES WITH THE MATERIAL THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. IF AN ISSUE IS FOUND DURING THE REVIEW, ESCALATION MAY BE REQUIRED, WHICH COULD RESULT IN A PRODUCT RECALL. THE TIBIAL INSERT MANUFACTURING LOT INVOLVED IN THIS CASE HAS ALREADY BEEN RECALLED FROM THE FIELD DUE TO THE NON-CONFORMING PRODUCT PACKAGING DETAILED ABOVE. THEREFORE, ADDITIONAL MANUFACTURING REVIEW HAS BEEN DEEMED UNNECESSARY AND WILL NOT BE CONDUCTED AT THIS TIME. A REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF TIBIAL LOOSENING, PROSTHESIS WEAR, AND FEMORAL LOOSENING 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, 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.

    Description of Event or Problem · 0

    REPORT #3 OF 3 FOR THIS EVENT. IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, A FEW WEEKS LATER, THE PATIENT EXPERIENCED PAIN. ONE (1) YEAR, FIVE (5) MONTHS LATER, THE PATIENT REPORTS PAIN AND DISSATISFACTION WITH IMPLANT FUNCTION. AS A RESULT, THE PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE DUE TO LOOSE TIBIA. IT WAS NOTED THE TIBIA WAS LOOSE WITH ONLY FIBROUS INGROWTH AND THE FEMUR HAD MINIMAL BONE INGROWTH. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. ADDITIONALLY, IT WAS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAS SUFFERED SEVERE PAIN AND LOSS OF MOBILITY DUE TO PROSTHESIS WEAR. NO ADDITIONAL INFORMATION IS AVAILABLE. 510K; K171045 CONCOMITANT PRODUCTS: - TRULIANT PS POR FEM PS POR RIGHT SZ 4.5(CAT#02-020-12-0345/SERIAL# 5758187) - TRULIANT TIB IMP PS INSERT SZ 4.5 9MM(CAT#02-022-35-4509/SERIAL# 5316760) - ADVANCED PATELLA 32MM 3 PEG IMPLANT(CAT#200-07-32/SERIAL# 6857967)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1087214 TRULIANT TIB IMP PS INSERT SZ 4.5 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862304520

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Hospitalization| R SEE H11