BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 11MM

    MDR report key: 17106974 · Received June 12, 2023

    Report

    Report Number
    1038671-2023-01317
    Event Type
    Injury
    Date Received
    June 12, 2023
    Date of Event
    September 15, 2022
    Report Date
    December 27, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173720
    PMA / PMN Number
    K110547
    Removal / Correction Number
    Z-0021-2022
    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

    D2B: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. D10. CONCOMITANTS: 4745380, 02-012-41-5050 - LOGIC TIBIA TRAPTRAY CEM SZ 5F/5T. 5685251, 02-020-11-0350 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 5. 5914779, 200-02-41 - THREE PEG PATELLA 41MM. 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, INSTABILITY, AND LOSS OF RANGE OF MOTION 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

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL RIGHT KNEE TOTAL ARTHROPLASTY ON (B)(6) 2019, AND THEN HAD A REVISION PROCEDURE ON (B)(6) 2022; APPROXIMATELY 3 YEARS, 4 MONTHS, AFTER INITIAL IMPLANT. REVISION OPERATIVE REPORT OF (B)(6) 2022. POSTOPERATIVE DIAGNOSIS: FAILED RIGHT TOTAL KNEE REPLACEMENT SECONDARY TO BEARING SURFACE WEAR. FINDINGS: THE PATIENT DID WELL FOR APPROXIMATELY 18 MONTHS AND THEN PRESENTED WITH RECURRENT SWELLING IN THE KNEE WITH SIGNS OF DRAMATIC SYNOVIAL EXPANSION WITH ACCUMULATION OF SYNOVIAL FLUID IN THE KNEE. THE KNEE WAS ALSO SOMEWHAT LAX WITH INCREASED LAXITY IN BOTH CORONAL AND SAGITTAL PLANES. RADIOGRAPHS SHOWED WELL-FIXED COMPONENTS. RADIOGRAPHS ALSO SHOWED WASHOUT OF THE CEMENT FROM UNDER THE MEDIAL TIBIAL PLATEAU. THERE WAS EXUBERANT FOREIGN BODY REACTION AND EXPANSION OF THE SYNOVIAL MEMBRANE. THERE WERE GROSSLY VISIBLE POLYETHYLENE PARTICLES IMBEDDED IN THE SOFT TISSUES OF THE KNEE. UNDER THE MEDIAL TIBIAL PLATEAU, THERE WAS OSTEOLYTIC REPLACEMENT OF THE CEMENT MANTLE. THE FEMORAL AND TIBIAL COMPONENTS REMAINED WELL FIXED AS DID THE PATELLAR COMPONENT, BUT THERE WAS AN AREA OF CEMENT WASHOUT UNDER THE MEDIAL TIBIAL PLATEAU. THE TIBIAL POLYETHYLENE INSERT SHOWED GROSS DELAMINATION AND MECHANICAL WEAR CONSISTENT WITH ADVANCED OXIDATION OF THE INSERT. DRESSINGS WERE APPLIED. THE PATIENT WAS AWAKENED, TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271130 LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 11MM SEE H10 JWH EXACTECH, INC. 02-012-44-5011 10885862173720

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention SEE H10.