BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF MP SLOT POST CUT GD MED

    MDR report key: 15355254 · Received September 5, 2022

    Report

    Report Number
    3002806535-2022-00373
    Event Type
    Injury
    Date Received
    September 5, 2022
    Date of Event
    August 4, 2022
    Report Date
    November 17, 2022
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LXH
    UDI-DI
    05019279440023
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOREIGN SOURCE: TAIWAN. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THAT THE PIN (37-100025-5) THAT LOCKS THE BLUE POMALUX PLUG (32-420326-2) INTO THE MAIN BODY OF THE CUTTING GUIDE HAS FALLEN OUT. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. DEVICE IS USED FOR TREATMENT. RADIOGRAPHS WERE PROVIDED AND THEY APPEAR TO CONFIRM THE PIN WAS DISCOVERED IN THE PATIENT'S KNEE POSTOPERATIVELY. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D9, G3, G6, H1, H2, H3, H6, H10. VISUAL EXAMINATION OF THE RETURNED PRODUCT CONFIRMS THAT THE PIN LOCKING THE POMALUX PLUG IN PLACE IS LOOSE AND ABLE TO BE REMOVED WITHOUT EFFORT. THE INSTRUMENT SHOWS SIGNS OF BEING WELL USED WITH INDENTS VISIBLE OVER THE WHOLE BODY. A DESIGN CHANGE TOOK PLACE IN 2018 TO WELD THE PIN IN PLACE AS OPPOSED TO GLUING IN PLACE WITH LOCTITE. THE INSTRUMENT WAS MANUFACTURED IN OCT 2017 AND HAS MOST LIKELY BEEN IN THE FIELD FOR 5 YEARS. THE EVALUATION OF THE RETURNED PRODUCT DOES NOT ALTER THE FINDINGS OF THE PREVIOUS REPORTED INVESTIGATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED: THAT THE POSTOPERATIVE X-RAY SHOWED THAT THERE WAS A FOREIGN BODY IN THE JOINT CAVITY AS RESULT OF THE PIN FROM THE INSTRUMENT DETACHING DURING THE PROCEDURE. THE PATIENT UNDERWENT SURGERY TO REMOVE THE FOREIGN BODY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE, NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274742 OXF MP SLOT POST CUT GD MED KNEE INSTRUMENTS LXH BIOMET UK LTD. N/A ZB170901 05019279440023

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H