BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT PS CEM FEM PS CEM LEFT SZ 1.5

    MDR report key: 20332542 · Received September 30, 2024

    Report

    Report Number
    1038671-2024-03732
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    January 23, 2023
    Report Date
    August 12, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862314406
    PMA / PMN Number
    K170240
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: 10000219053 A10012 - GPS IMPLANT KIT V2 (B)(4). 02-012-60-1425 - TRU STEM EXT 14MM X 25MM (B)(4). 02-020-11-0215 - TRULIANT PS CEM FEM PS CEM LEFT SZ 1.5 (B)(4). 02-022-45-1515 - TRULIANT TIB FIT TRAY CEM SZ 1.5F / 1.5T (B)(4). 200-02-29 - THREE PEG PATELLA 29MM 6172608. 204-70-00 - TIBIAL STEM EXT. SCREW. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL [ENTER RECALL #]; 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D4, G4, H6. MDR SECTION CODES UPDATED/CORRECTED: B, G. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF 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 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 ¿ USA (MDL NO. (B)(4)). PATIENT ID: (B)(6). RELATED (B)(4). AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2019. APPROXIMATELY 3 YEARS AND 2 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023. 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. 02-022-35-1509 - TRULIANT TIB IMP PS INSERT SZ 1.5, 9MM. SN: (B)(6). CONCOMITANT DEVICES: (B)(4) A10012 - GPS IMPLANT KIT V2. (B)(4) 02-012-60-1425 - TRU STEM EXT 14MM X 25MM. (B)(4) 02-020-11-0215 - TRULIANT PS CEM FEM PS CEM LEFT SZ 1.5. (B)(4) 02-022-45-1515 - TRULIANT TIB FIT TRAY CEM SZ 1.5F / 1.5T. (B)(4) 200-02-29 - THREE PEG PATELLA 29MM. (B)(4) 204-70-00 - TIBIAL STEM EXT. SCREW. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. (B)(4), AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE. AS DIRECTED BY QA MANAGEMENT: THIS LEGAL COMPLAINT FOR POLYETHYLENE ISSUES OCCURRED IN THE US. THE EVENT DID NOT OCCUR IN, NOR IS IT REPORTABLE FOR AUSTRALIA, BRAZIL, CANADA, EEA/EU, JAPAN, TAIWAN, OR GREAT BRITAIN, EXCLUDING NORTHERN IRELAND. THEREFORE, ONLY THE US REPORTABILITY DETERMINATION WILL BE ASSESSED. (B)(6) 2024 INVESTIGATION SUMMARY: THE REASON FOR THE REVISION REPORTED IN (B)(4) CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. HOWEVER, THE REPORTED PROSTHESIS WEAR COULD NOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF MANUFACTURING, USER, OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO IMAGES, RADIOGRAPHS, OR RELEVANT CLINICAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1061150 TRULIANT PS CEM FEM PS CEM LEFT SZ 1.5 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862314406

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11.