BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 11MM

    MDR report key: 16504812 · Received March 8, 2023

    Report

    Report Number
    1038671-2023-00397
    Event Type
    Injury
    Date Received
    March 8, 2023
    Date of Event
    January 1, 2023
    Report Date
    January 10, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173645
    PMA / PMN Number
    K110547
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H3: BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION. THE PATIENT HAS BILATERAL KNEE REPLACEMENTS. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 0

    CONCOMITANTS: 6112661, 02-010-01-0340 - LOGIC FEMORAL PS CEM RIGHT SZ 4; 2019405, 02-012-45-4050 - LGC TIBIAL FIT TRAY CEM SZ 4F / 5T; 6331769, 200-02-35 - THREE PEG PATELLA 35MM; 323871, 203-96-40 - (11-3973) STRYKER SYS 6 90X25X1.27. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL CHANGE INVESTIGATION RESULTS. NO OTHER INFORMATION IS AVAILABLE. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR 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 A LEGAL NOTIFICATION THAT A PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2020, UNDERWENT A REVISION PROCEDURE ON AN UNKNOWN DATE TO REPLACE THE PRODUCT. THE INJURIES THE PATIENT SUSTAINED AS A RESULT OF THE RECALL PRODUCT HAVE RESULTED IN ONGOING TREATMENT. NO PRODUCT RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED VIA LEGAL DEPARTMENT- REVISION OPERATIVE REPORT OF (B)(6) 2023 FOR REVISION OF RIGHT TOTAL KNEE REPLACEMENT WITH EXTENSIVE DEBRIDEMENT AND COMPLETE SYNOVECTOMY OF RIGHT KNEE WITH POLYETHYLENE LINER EXCHANGE FOR WEAR. THE PATIENT WAS DOING WELL AND THEN HE STARTED DEVELOPING SOME SWELLING IN THE KNEE AS WELL AS SOME INSTABILITY EPISODE. DISCOMFORT INCREASED SUBSTANTIALLY AFTER A TWISTING INJURY. THERE WAS EXTENSIVE SYNOVITIS NOTED IN THE SUPRAPATELLAR POUCH CONSISTENT WITH POLYETHYLENE WEAR, THIS INVOLVED AN EXTENSIVE SYNOVECTOMY. THE WEAR WAS NOTED ABOUT THE POST AS WELL AS DEEP SCALLOPING PRESENT INVOLVING THE MEDIAL ASPECT OF THE POLY INSERT. PATIENT WAS REVISED TO EXACTECH DEVICES. THE POLY INSERT WAS SENT FOR CLEANING AND TO BE RETURNED TO THE SURGEON. DRESSINGS WERE APPLIED, THE PATIENT WAS AWAKENED AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION, THERE WERE NO COMPLICATIONS. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1727944 LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 11MM UNK 10885862173645

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention