BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 15MM

    MDR report key: 17500162 · Received August 10, 2023

    Report

    Report Number
    1038671-2023-01926
    Event Type
    Injury
    Date Received
    August 10, 2023
    Date of Event
    September 22, 2022
    Report Date
    January 2, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173621
    PMA / PMN Number
    K110547
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: (B)(6), 02-010-01-0335 - LOGIC FEMORAL PS CEM RIGHT SZ 3.5. (B)(6), 02-012-41-3545 - LOGIC TIBIA TRAPTRAY CEM SZ 3.5F/4.5T. (B)(6), 200-02-38 - THREE PEG PATELLA 38MM. (B)(6), 201-78-12 - HOLDING PIN LG HEAD SHARP POINT MED 2PK. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    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-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. D10: CONCOMITANTS: (B)(6) 02-010-01-0335 - LOGIC FEMORAL PS CEM RIGHT SZ 3.5 (B)(6) 02-012-41-3545 - LOGIC TIBIA TRAPTRAY CEM SZ 3.5F/4.5T (B)(6) 200-02-38 - THREE PEG PATELLA 38MM (B)(6) 201-78-12 - HOLDING PIN LG HEAD SHARP POINT MED 2PK THE FOLLOWING SECTIONS WERE UPDATED: G1, H6 THE FOLLOWING SECTIONS WERE CORRECTED: B1, B2, H6 THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND INSTABILITY OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE REPORTED WEAR MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. 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

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2018. APPROXIMATELY 4 YEARS AND 7 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. 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 (B)(6) 2022. DIAGNOSIS: FAILED RIGHT KNEE REPLACEMENT SECONDARY TO WEAR OF THE BEARING SURFACE FINDINGS: FOUND EXUBERANT FOREIGN BODY REACTION, A GROSS CONTAMINATION OF THE SYNOVIUM WITH POLYETHYLENE DEBRIS, AND VERY SIGNIFICANT WEAR OF THE POLYETHYLENE INSERT WITH TREMENDOUS LOSS OF SUBSTANCE FROM THE MEDIAL ASPECT OF THE IMPLANT. THE OTHER IMPLANTS WERE WELL FIXED AND IN GOOD CONDITION. THE PATIENT WAS AWAKENED AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761732 LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 15MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 15MM UNK 10885862173621

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Unknown Hospitalization| R SEE H10| SEE H11.