BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 4 11MM

    MDR report key: 19760569 · Received July 17, 2024

    Report

    Report Number
    1038671-2024-02415
    Event Type
    Injury
    Date Received
    July 17, 2024
    Date of Event
    January 20, 2023
    Report Date
    November 8, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001894
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT DEVICES (B)(6) 02-010-01-0240 - LOGIC FEMORAL PS CEM LEFT SZ 4; (B)(6) 02-012-45-4030 - LGC TIBIAL FIT TRAY CEM SZ 4F / 3T; (B)(6) 200-02-35 - THREE PEG PATELLA 35MM. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0021-2022; 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.

    Additional Manufacturer Narrative · 0

    H6: CORRECTED HEALTH EFFECT CLINICAL CODE, AND TYPE OF INVESTIGATION. MANUFACTURER NARRATIVE UPDATED: THE REASON FOR THE REVISION REPORTED 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. ADDITIONALLY, THE DEVICES WERE IMPLANTED FOR OVER TEN YEARS PRIOR TO THE REPORTED FAILURE(S). HOWEVER, THE REPORTED PROSTHESIS WEAR COULD NOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF 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.

    Description of Event or Problem · 0

    LEGAL CASE ¿ USA (MDL NO. (B)(4)). PATIENT ID: (B)(6) + LEFT KNEE. (B)(6) IS ASSOCIATED WITH THIS CASE THE PATIENT HAS FILED A SHORT-FORM. COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044, 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. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022. 02-012-35-4011 - LOGIC TIBIA PS MOD INSRT SZ 4 11MM. SERIAL: (B)(6). 510K: K033883. UDI: (B)(4). PRODUCT CODE: JWH. X-RAY: NO. OPERATIVE NOTES: NO. CONCOMITANT DEVICES: (B)(6) 02-010-01-0240 - LOGIC FEMORAL PS CEM LEFT SZ 4; (B)(6) 02-012-45-4030 - LGC TIBIAL FIT TRAY CEM SZ 4F / 3T; (B)(6) 200-02-35 - THREE PEG PATELLA 35MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2143209 LOGIC TIBIA PS MOD INSRT SZ 4 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001894

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H11.