BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 16807454 · Received April 25, 2023

    Report

    Report Number
    1038671-2023-00821
    Event Type
    Injury
    Date Received
    April 25, 2023
    Date of Event
    April 18, 2023
    Report Date
    December 16, 2024
    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

    05-NOV-1948.

    Additional Manufacturer Narrative · 0

    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 MANUFACTURING, USER, AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND PRODUCT INFORMATION WERE NOT PROVIDED. H6: CORRECTED HEALTH EFFECT, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DEPARTMENT - REVISION OPERATIVE REPORT OF (B)(6) 2023. PREOPERATIVE DIAGNOSIS: POLYETHYLENE WEAR, RECALLED IMPLANT. THIS PATIENT HAD PRIMARY L KNEE SURGERY (B)(6) 2017. THEY HAD L KNEE REVISION (B)(6) 2023, APPROXIMATELY 5 YEARS AND 7 MONTHS AFTER THEIR INITIAL SURGERY. THE POLYETHYLENE WAS NOTED TO BE GROSSLY WORN, NOTABLY AT THE POST MORE THAN OTHER AREAS. ONCE THE FEMORAL COMPONENT WAS REMOVED, THERE WAS NOTED TO BE AORI TYPE IIB BONE LOSS, WORSE ON THE LATERAL COMPARED TO MEDIAL SIDE, AND OSTEOLYSIS AFFECTING BOTH POSTERIOR CONDYLES. THE TIBIAL COMPONENT WAS FOUND TO BE GROSSLY INTACT, NOT LOOSE. BONY INVENTORY AFTER REMOVAL CEMENT OF THE TIBIA REVEALED TYPE I BONE LOSS. THERE WAS ALSO GROSS WEAR OF THE PATELLAR COMPONENT. PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. POST-OPERATIVE PLAN: THE PATIENT BE ALLOWED TO WEIGHT-BEAR AS TOLERATED. THEY WILL RECEIVE PERIOPERATIVE ANTIBIOTICS AND BE STARTED ON DVT PROPHYLAXIS. THEY WILL BE DISCHARGED HOME FROM THE HOSPITAL WHEN THEY ARE COMFORTABLE AND HAVE MET ALL PT GOALS. 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
    1188334 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention