BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM RIGHT SZ 2

    MDR report key: 20133925 · Received September 4, 2024

    Report

    Report Number
    1038671-2024-03251
    Event Type
    Injury
    Date Received
    September 4, 2024
    Date of Event
    February 1, 2023
    Report Date
    October 25, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001214
    PMA / PMN Number
    K033883
    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 (B)(6) 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T ((B)(6) 200-02-32 - THREE PEG PATELLA 32MM (B)(6) 02-012-35-2011 - LOGIC TIBIA PS MOD INSRT SZ 2 11MM THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF 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

    H6: ADDED THE FOLLOWING: HEALTH EFFECT - MEDICAL DEVICE PROBLEM CODES.

    Description of Event or Problem · 0

    **28-AUG-2024 ADDITIONAL INFORMATION** LEGAL CASE ¿ (B)(4). PATIENT ID:(B)(6), (B)(4), LEFT KNEE IS ASSOCIATED WITH THIS CASE. IT IS REPORTED VIA LEGAL DOCUMENTATION (SHORT FORM COMPLAINT ATTACHED) THAT PLAINTIFF UNDERWENT RIGHT KNEE REVISION (B)(6) 2023. 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 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T SERIAL: (B)(6) 510K: K101981 UDI: (B)(4). PRODUCT CODE: JWH X-RAY: NO OPERATIVE NOTES: NO CONCOMITANT DEVICES: (2729255) 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T (2861615) 02-010-01-0320 - LOGIC FEMORAL PS CEM RIGHT SZ 2 (2955695) 200-02-32 - THREE PEG PATELLA 32MM **ORIGINAL SUMMARY** LEGAL CASE USA ¿ LORETTA REVIS RK REV AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON 3 MAR 2014. APPROXIMATELY 8 YEARS AND 11 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON 1 FEB 2023. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION OP REPORT ON 1 FEB 2023 DIAGNOSIS: FAILED RIGHT TOTAL KNEE DUE TO PREMATURE POLY WEAR AND FAILED FEMORAL COMPONENT DUE TO OSTEOLYSIS FINDINGS: THERE WAS FOUND TO BE A CLEAN WOUND WITH CLEAR SYNOVIAL JOINT FLUID. THERE WAS FOUND TO BE SEVERE WEAR OF THE POLYETHYLENE OF THE TIBIAL COMPONENT. THERE WAS A GROSSLY LOOSE FEMORAL COMPONENT THAT WAS LOOSE FROM THE CEMENT MANTLE. THERE WAS NO CEMENT ADHERENT TO THE BACK SIDE OF THE FEMORAL COMPONENT. THE TIBIAL COMPONENT WAS FOUND TO BE WELL FIXED TO BONE AND THE PATELLAR COMPONENT WAS FOUND TO BE WELL FIXED. EBI INITIAL SURGERY ATTACHED. HISTORICAL RECORD AND SMARTSOLVE SEARCHED FOR SN/PATIENT NAME WITH NO RESULTS. 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. 2841515 02-012-35-3011 - LOGIC TIBIA PS MOD INSRT SZ 3 11MM ***SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K033883 RECALL: Z-0021-2022 CONCOMITANTS: 2837911 02-010-01-0230 - LOGIC FEMORAL PS CEM LEFT SZ 3 2833339 02-012-45-3020 - LGC TIBIAL FIT TRAY CEM SZ 3F / 2T 2858564 200-02-32 - THREE PEG PATELLA 32MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065243 LOGIC FEMORAL PS CEM RIGHT SZ 2 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001214

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention| H SEE H11