BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 3.5 9MM

    MDR report key: 16772746 · Received April 19, 2023

    Report

    Report Number
    1038671-2023-00755
    Event Type
    Injury
    Date Received
    April 19, 2023
    Date of Event
    December 15, 2022
    Report Date
    January 3, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304346
    PMA / PMN Number
    K152170
    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

    PENDING INVESTIGATION. D10. CONCOMITANTS: 6482856 02-020-11-0235 - TRULIANT PS CEM FEM PS CEM LEFT SZ 3.5; 6378932 02-022-45-3525 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 2.5T; 360341 02-029-99-1001 - FLUTED HEADLESS PIN 3.0" SQUARE HEAD; 359010 02-029-99-1002 - THREADED HEAD PIN 2.3" SQUARE HEAD; 6516819 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT.

    Additional Manufacturer Narrative · 0

    RECALL NUMBER: Z-0023-2022. 1038671-2025-00050 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2025-00050. D10: CONCOMITANTS: (B)(6), 02-020-11-0235 - TRULIANT PS CEM FEM PS CEM LEFT SZ 3.5; (B)(6), 02-022-45-3525 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 2.5T; (B)(6), 02-029-99-1001 - FLUTED HEADLESS PIN 3.0" SQUARE HEAD; (B)(6), 02-029-99-1002 - THREADED HEAD PIN 2.3" SQUARE HEAD; (B)(6), 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, INSTABILITY, 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 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 (B)(6) LK REV. RELATED (B)(4). AS REPORTED VIA LEGAL DOCUMENTATION, ON (B)(6) 2020, THE PATIENT UNDERWENT A TOTAL LEFT KNEE REPLACEMENT SURGERY AND WAS IMPLANTED WITH A NOW-RECALLED EXACTECH TRULIANT DEVICE IN HER LEFT KNEE. FOLLOWING THE SURGERY, THE PATIENT BEGAN EXPERIENCING INCREASING PAIN, BUCKLING, SWELLING, AND INFLAMMATION. THESE SYMPTOMS IMPACTED THEIR MOBILITY, RESULTING IN A SEVERE LIMP. THEY ALSO EXPERIENCED A CONSTANT SENSATION OF THE PARTS IN HER KNEES SHIFTING. IN (B)(6) 2022, THE PATIENT RECEIVED A RECALL LETTER REGARDING THE TRULIANT DEVICES THAT WERE IMPLANTED IN HER. ON (B)(6) 2022, SHE REPORTED TO HER PHYSICIAN WITH COMPLAINTS OF WORSENING PAIN AND SWELLING OF HER KNEES, AND INCREASING EPISODES OF BUCKLING. HER PHYSICIAN EXPLAINED THAT ¿ISSUES WITH FEMORAL LOOSENING¿ OF THE RECALLED IMPLANTS ARE ¿NOT EASILY SEEN ON XRAYS,¿ BUT THAT HE SUSPECTED ¿[SHE] IS LIKELY DEALING WITH LOOSE FEMORAL COMPONENTS AS WELL AS POSSIBLY SYNOVITIS RELATED TO EARLY POLYETHYLENE WEAR DUE TO THE RECALLED INSERTS.¿ DUE TO WORSENING PAIN, SWELLING, INSTABILITY, AND ¿FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO A RECALLED POLYETHYLENE INSERT AND ASEPTIC LOOSENING OF THE FEMORAL COMPONENT,¿ THE PATIENT UNDERWENT A LEFT KNEE REPLACEMENT REVISION SURGERY ON (B)(6) 2022, APPROXIMATELY 2 YEARS 5 MONTHS AFTER THEIR INITIAL KNEE REPLACEMENT. 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. (B)(4) 02-022-35-3509 - TRULIANT TIB IMP PS INSERT SZ 3.5 9MM. SERIAL NUMBER (B)(4) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K152170 CONCOMITANTS: 6482856 02-020-11-0235 - TRULIANT PS CEM FEM PS CEM LEFT SZ 3.5 6378932 02-022-45-3525 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 2.5T 360341 02-029-99-1001 - FLUTED HEADLESS PIN 3.0" SQUARE HEAD 359010 02-029-99-1002 - THREADED HEAD PIN 2.3" SQUARE HEAD 6516819 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520399 TRULIANT TIB IMP PS INSERT SZ 3.5 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 3.5 9MM UNK 10885862304346

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention| H