BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 20645620 · Received November 8, 2024

    Report

    Report Number
    1038671-2024-04323
    Event Type
    Injury
    Date Received
    November 8, 2024
    Date of Event
    February 20, 2023
    Report Date
    March 19, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B5. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL NOTIFICATION, THAT PATIENT, UNDERWENT INITIAL RIGHT KNEE REPLACEMENT SURGERY IN 2015. HE WAS IMPLANTED WITH AN OPTETRAK DEVICE. ON (B)(6) 2023, PLAINTIFF IS SCHEDULED TO UNDERGO RIGHT KNEE REVISION SURGERY, APPROXIMATELY 8 YEARS 2 MONTHS POST INITIAL PROCEDURE, TO REMOVE THE FAILED POLYETHYLENE LINER DUE TO ACCELERATED AND PREVENTABLE WEAR OF THE POLYETHYLENE TIBIAL INSERT. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

    Description of Event or Problem · 0

    LEGAL CASE - UPDATED INFORMATION RECEIVED FROM LEGAL (B)(6)2023, REVIEWED BY (B)(6), RN (B)(6) 2024- PATIENT WAS REVISED ON (B)(6)2023, REVISED TO OPTETRAK POLY AND PATELLA. OPERATIVE REPORT OF (B)(6) 2023-POSTOPERATIVE DIAGNOSIS: 1. WEAR-INDUCED SYNOVITIS, RIGHT KNEE ARTHROPLASTY. 2. POLYETHYLENE WEAR, LAXITY, RIGHT KNEE ARTHROPLASTY. ASSESSED THE STABILITY OF THE FEMORAL AND TIBIAL COMPONENTS. THEY WERE STABLE AND WELL FIXED. THE PATIENT HAD SORT OF VILLOUS NODULAR SYNOVIUM WHICH IS TYPICALLY SEEN WITH EITHER CEMENT DISEASE OR POLY WEAR. THE TIBIAL POLYETHYLENE WAS REMOVED. THERE WAS SOME DELAMINATED WEAR ALONG THE POSTERIOR ASPECTS, BUT OVERALL, THE POLY DID NOT LOOK TERRIBLE. THERE WAS MORE WEAR ACTUALLY ON THE PATELLAR COMPONENT. THE PATIENT WAS TAKEN TO THE PACU POSTOP IN STABLE CONDITION. THERE IS NO OTHER INFORMATION AVAILABLE. (OP REPORT ATTACHED). (B)(4), SERIAL #: (B)(6) - /Z-0021-2022/K110547. ORIGINAL INFORMATION RECEIVE. IT WAS REPORTED VIA LEGAL NOTIFICATION, THAT PATIENT, UNDERWENT INITIAL RIGHT KNEE REPLACEMENT SURGERY IN 2015. HE WAS IMPLANTED WITH AN OPTETRAK DEVICE. ON (B)(6) 2023, PLAINTIFF IS SCHEDULED TO UNDERGO RIGHT KNEE REVISION SURGERY, APPROXIMATELY 8 YEARS 2 MONTHS POST INITIAL PROCEDURE, TO REMOVE THE FAILED POLYETHYLENE LINER DUE TO ACCELERATED AND PREVENTABLE WEAR OF THE POLYETHYLENE TIBIAL INSERT. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1903447 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention| H