BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 11MM

    MDR report key: 18517447 · Received January 16, 2024

    Report

    Report Number
    1038671-2024-00090
    Event Type
    Injury
    Date Received
    January 16, 2024
    Date of Event
    February 24, 2023
    Report Date
    December 11, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173485
    PMA / PMN Number
    K110547
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RECALL NUMBER: Z-0021-2022. 1038671-2024-04776, 1038671-2024-04775. D10: CONCOMITANTS: 02-010-01-0320 - LOGIC FEMORAL PS CEM RIGHT SZ 2 (B)(6). 02-012-45-2010 - LGC TIBIAL FIT TRAY CEM SZ 2F / 1T (B)(6). 200-02-29 - THREE PEG PATELLA 29MM (B)(6). 201-78-25 - SMALL HEADED SHARP PIN, 1 1/8" 4 PACK (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2024-04776, 1038671-2024-04775. 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. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G1, H6. THE FOLLOWING SECTIONS WERE CORRECTED: B1, B2, G1, H6. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, FEMORAL LOOSENING, AND TIBIAL 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.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 02-010-01-0320 - LOGIC FEMORAL PS CEM RIGHT SZ 2 2818197; 02-012-45-2010 - LGC TIBIAL FIT TRAY CEM SZ 2F / 1T 2503474; 200-02-29 - THREE PEG PATELLA 29MM 2584462; 201-78-25 - SMALL HEADED SHARP PIN, 1 1/8" 4 PACK 2659897; PENDING INVESTIGATION.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2013. APPROXIMATELY 9 YEARS AND 4 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 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 (B)(6) 2023DIAGNOSIS: FAILED RIGHT KNEE REPLACEMENT FINDINGS: LOOSE FEMORAL AND TIBIAL IMPLANTS - REMOVED EASILY WITH MODERATE BONE LOSS. VERY LARGE POSTERIOR MEDIAL FLUID COLLECTION - THICK VISCOUS LIGHT BROWN - UNUSUAL APPEARANCE LIKELY RELATED TO SEVERE POLY WEAR. THERE WAS EXTENSIVE SOFT TISSUE DEBRIS THROUGHOUT THE KNEE JOINT CONSISTENT WITH A SYNOVITIS FROM A POLYETHYLENE REACTION TO THE TISSUES. THERE WAS TINY, SMALL BALLS OF LIGHT BROWN SYNOVIUM ALONG WITH A "PESUDO-CAPSULE" OF DENSE SOFT TISSUE RIND. THE SURGEON EXAMINED THE POLYETHYLENE - EXCESSIVE WEAR WAS PRESENT WITH SIGNS OF OXIDATION/YELLOW DISCOLORATION, PITTING, CRACKING AND DELAMINATION OF THE POLY. DISTAL FEMORAL BONE LOSS WAS MODERATE. THE TIBIAL BONE LOSS WAS EXTENSIVE AND REQUIRED PLACEMENT OF A TIBIAL CONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818204 LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862173485

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention| H SEE H10