BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 13MM

    MDR report key: 19859750 · Received July 30, 2024

    Report

    Report Number
    1038671-2024-02584
    Event Type
    Injury
    Date Received
    July 30, 2024
    Date of Event
    August 29, 2023
    Report Date
    November 18, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K110547
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-2021-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    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.

    Description of Event or Problem · 0

    LEGAL CASE - USA. PATIENT ID: (B)(6) + RIGHT KNEE. IT WAS REPORTED THAT APPROXIMATELY 117 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS DEBRIS SYNOVITIS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PREOPERATIVE AND POSTOPERATIVE DIAGNOSES INDICATED DEBRIS SYNOVITIS STATUS POST RIGHT TOTAL KNEE ARTHROPLASTY. THE PATIENT HAD MODERATE SYNOVITIS. THE FEMUR AND TIBIA WERE NOT LOOSE. THE SPACER LOOKED GROSSLY INTACT. BASED ON THE SYNOVITIS AND FAILURE OF ARTHROSCOPIC DEBRIDEMENT AND SYNOVECTOMY, IT WAS ELECTED TO DO A COMPLETE OPEN SYNOVECTOMY AND A REVISED SPACER. THE PATIENT HAD A 13 SPACER WHICH WAS REVISED TO A 15. THIS FIT PERFECTLY. NO OPERATIVE COMPLICATIONS. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022. 02-012-44-3013 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 13MM; SERIAL: (B)(6); 510K: K110547; UDI: (B)(4); PRODUCT CODE: JWH; X-RAY: NO; OPERATIVE NOTES: YES. CONCOMITANT DEVICES: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199620 LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R