BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 2.5 11MM

    MDR report key: 16742796 · Received April 14, 2023

    Report

    Report Number
    1038671-2023-00696
    Event Type
    Injury
    Date Received
    April 14, 2023
    Date of Event
    August 31, 2021
    Report Date
    March 26, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304186
    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

    CONCOMITANTS: SERIAL #: (B)(4), CATEGORY #: 200-07-29 - ADVANCED PATELLA 29M 3 PEG IMPLANT. SERIAL #: (B)(4), CATEGORY #: 02-012-60-1425 - LOGIC STEM EXT 14MM X 25MM. SERIAL #: (B)(4), CATEGORY #: 02-022-45-2525 - TRULIANT TIB FIT TRAY CEM SZ 2.5F / 2.5T. SERIAL #: (B)(4), CATEGORY #: 204-70-00 - TIBIAL STEM EXT. SCREW. SERIAL #: (B)(4), CATEGORY #: 02-020-11-0225 - TRULIANT PS CEM FEM PS CEM LEFT SZ 2.5. ADDITIONAL INFORMATION INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION- B7, D8, H6. HEALTH EFFECT - CLINICAL CODE-PAIN. HEALTH EFFECT - IMPACT CODE- STATED TO BE PENDING REVISION SURGICAL PROCEDURE. H6. INVESTIGATION RESULTS- THE TRULIANT TIB IMP PS INSERT DEVICE WITH SERIAL NUMBER (B)(6) IS NOT AFFECTED BY THE FDA RECALL. THE CAUSE OF THE PATIENT¿S PAIN CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. THE PATIENT HAS BILATERAL KNEE REPLACEMENTS. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THERE IS NO OTHER INFORMATION AVAILABLE. CORRECTION-, B3, B5-THIS PATIENT WAS NOT REVISED, D6B- THIS PATIENT WAS NOT REVISED, F10-BLANK, THIS IS A MANUFACTURER¿S REPORT, H6 HEALTH EFFECT - IMPACT CODE-THIS PATIENT WAS NOT REVISED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. ADDITIONAL INFORMATION FIELDS: A2, B2, B5, G, G2, G3, H6-CLINICAL CODES. CORRECTED FILEDS: B3(DELETE DATE-NO EVENT), D6B (DELETE-NO EVENT), E1, H6 IMPACT CODE, MEDICAL DEVICE PROGRAM CODE, COMPONENT CODE.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REPORTED EVENT CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED, BUT MAY HAVE BEEN DUE TO PROSTHESIS WEAR. 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

    LEGAL CASE PROSE (B)(6). RELATED CASE: (B)(4). PER A REPORT FROM THE LEGAL DEPARTMENT THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2019. APPROXIMATELY 2 YEARS 4 MONTHS POST INITIAL SURGERY THE PATIENT HAD A RIGHT KNEE REVISION. 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. SERIAL #: (B)(4), CATEGORY #: 02-022-35-2511 - TRULIANT TIB IMP PS INSERT SZ 2.5 11MM, THE SERIAL NUMBER (B)(4), IS NOT AFFECTED BY THE RECALL. 510K: K152170. CONCOMITANTS: SERIAL #: (B)(4), CATEGORY #: 200-07-29 - ADVANCED PATELLA 29M 3 PEG IMPLANT. SERIAL #: (B)(4), CATEGORY #: 02-012-60-1425 - LOGIC STEM EXT 14MM X 25MM. SERIAL #: (B)(4), CATEGORY #: 02-022-45-2525 - TRULIANT TIB FIT TRAY CEM SZ 2.5F / 2.5T. SERIAL #: (B)(4), CATEGORY #: 204-70-00 - TIBIAL STEM EXT. SCREW. SERIAL #: (B)(4), CATEGORY #: 02-020-11-0225 - TRULIANT PS CEM FEM PS CEM LEFT SZ 2.5.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2019. IT IS STATED THAT THE PATIENT HAS SUFFERED AND CONTINUES TO SUFFER PERMANENT, AND DEBILITATING INJURES AND DAMAGES, INCLUDING BUT NOT LIMITED TO SIGNIFICANT PAIN AND DISCOMFORT, SWELLING, STIFFNESS, GRINDING AND/OR POPPING OF THE KNEE, INABILITY TO BEAR WEIGHT, BUCKLING, GAIT IMPAIRMENT, AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGOING MEDICAL CARE, AND THAT THE PATIENT REQUIRES REVISION SURGERY. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 72 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN AND DISCOMFORT, SWELLING, STIFFNESS, GRINDING AND/OR POPPING OF THE KNEE, INABILITY TO BEAR WEIGHT, BUCKLING, AND GAIT IMPAIRMENT. INITIAL SURGERY OPERATIVE NOTES WERE PROVIDED. AT THE TIME OF LEGAL NOTIFICATION, NO REVISION PROCEDURE HAD BEEN PERFORMED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393180 TRULIANT TIB IMP PS INSERT SZ 2.5 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 2.5 11MM UNK 10885862304186

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Other| R SEE H10