BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE++, SZ 2, 13MM

    MDR report key: 18956049 · Received March 21, 2024

    Report

    Report Number
    1038671-2024-00632
    Event Type
    Injury
    Date Received
    March 21, 2024
    Date of Event
    January 3, 2023
    Report Date
    November 25, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174338
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10. D10. CONCOMITANTS - PRODUCT INFORMATION: 4046820 02-010-03-0220 - LOGIC CR FEMORAL CEM, LEFT SZ 2; 4085592 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T; 4059669 200-02-32 - THREE PEG PATELLA 32MM; 4121632 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM; 4084696 204-70-00 - TIBIAL STEM EXT. SCREW PENDING INVESTIGATION. THERE IS NO OTHER INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6: COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. THE FOLLOWING SECTIONS WERE CORRECTED: H6: HEALTH EFFECT - CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE. 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. 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

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023, APPROXIMATELY 7 YEARS, 3 MONTHS AFTER INITIAL IMPLANT. REVISION OPERATIVE REPORT OF (B)(6) 2023- POSTOPERATIVE DIAGNOSIS: FAILED LEFT TOTAL KNEE ARTHROPLASTY. THERE WAS NOTED TO BE SIGNIFICANT PIECES OF POLYETHYLENE FLOATING IN THE JOINT. THE PATIENT¿S PREVIOUS POLYETHYLENE INSERT HAD FAILED CATASTROPHICALLY. THE TIBIA WAS WELL FIXED. THE PATIENT WAS TAKEN TO RECOVERY ROOM IN STABLE CONDITION. THE DEVICES WERE NOT RETURNED, THERE ARE NO IMAGES PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2555905 LOGIC CR TIB INSERT SLOPE++, SZ 2, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862174338

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H10