BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE +. SZ 3.5, 9 MM

    MDR report key: 17377884 · Received July 24, 2023

    Report

    Report Number
    1038671-2023-01748
    Event Type
    Injury
    Date Received
    July 24, 2023
    Date of Event
    July 5, 2023
    Report Date
    May 6, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862159281
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    H6: CORRECTED THE FOLLOWING: HEALTH EFFECT - CLINICAL CODE, IMPACT CODE, PROBLEM CODE, COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS G4: CORRECTED. D4: CORRECTED. H4: CORRECTED. D10: (B)(6), 02-010-03-0235 - LOGIC CR FEMORAL CEM, LEFT, SZ 3.5. (B)(6), 02-012-45-3535 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T. (B)(6), 02-012-48-3509 - LOGIC CR TIB INSERT SLOPE +. SZ 3.5, 9 MM. (B)(6), 200-02-32 - THREE PEG PATELLA 32MM. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, INSTABILITY AND/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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY 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. 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 LEFT KNEE REPLACEMENT ON (B)(6) 2016. PATIENT HAS STATED PAIN FOR APPROXIMATELY 2 YEARS. PATIENT STATED THAT ON DOCTOR SAW HIS LEFT KNEE X-RAY AND CONFIRMED A FAILED POLY. PATIENT IS SCHEDULED FOR REVISION SURGERY ON (B)(6) 2023. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED APPROXIMATELY 83 MONTHS AFTER LEFT TOTAL KNEE ARTHROPLASTY A PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE TO ADDRESS PAIN AND SWELLING OF THE KNEE APPROXIMATELY ONE YEAR PRIOR TO REVISION. POST OPERATIVE EVALUATION INDICATED ASYMMETRIC POLYETHYLENE WEAR WITH NEAR COMPLETE COLLAPSE OF THE MEDIAL COMPARTMENT. A REVISION OPERATIVE REPORT WAS PROVIDED. POST OPERATIVE DIAGNOSIS NOTED POLYETHYLENE WEAR OF THE LEFT KNEE PROSTHESIS AND SIGNIFICANT SYNOVITIS. INTRAOPERATIVELY THE SURGEON OBSERVED PROLIFIC SYNOVIUM WITHOUT INFECTION. POLYETHYLENE DEBRIS WAS OBSERVED IN SYNOVIAL FLUID AROUND THE JOINT. THE INSERT WAS INSPECTED AND NOTED TO BE WORN BOTH MEDIALLY AND LATERALLY. IT WAS NOTED THE POLYETHYLENE WEAR WAS QUITE EXTENSIVE, BUT THE POLYETHYLENE INSERT WAS NOT BROKEN THROUGH. THE LOCKING MECHANISM WAS STILL INTACT. IT WAS NOTED THERE WAS NO EVIDENCE OF METAL-ON-METAL WEAR. THEY POLYETHYLENE INSERT WAS EXCHANGED. THE PATIENT WAS AWAKENED FROM IV SEDATION AND TRANSFERRED TO A GURNEY AND TAKEN TO RECOVERY ROOM. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771185 LOGIC CR TIB INSERT SLOPE +. SZ 3.5, 9 MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED UNK 10885862159281

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Hospitalization| R SEE H11