BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULAR SURFACE WITH LOCKING SCREW

    MDR report key: 8900682 · Received August 16, 2019

    Report

    Report Number
    0001822565-2019-03436
    Event Type
    Injury
    Date Received
    August 16, 2019
    Date of Event
    July 23, 2019
    Report Date
    February 12, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K173057
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PERFORMED A VISUAL INSPECTION OF THE RETURNED ITEM # 00599403214 LOT # 62326587 IT EXHIBITS SIGNS OF BEING IMPLANTED NICKED / GOUGED IN THE ANTERIOR / DISTAL SURFACES. THE LCCK SUPPORT SCREW COMPONENT (00-5994-191-00) HAS DAMAGE TO THE THREADS AS THEY ARE COMPRESSED AND FRACTURED OFF ALL PIECES WERE NOT RETURNED. NO FRACTURE ANALYSIS CAN BE PERFORMED AS THE FRACTURED SURFACE WAS SEVERELY DAMAGED. AN INTRAOPERATIVE IMAGE WAS PROVIDED. THE SCREW WAS CONFIRMED TO BE IN A UPSIDE DOWN POSITION UPON OPENING THE JOINT. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN STEM. UNKNOWN TIBIAL TRAY. UNKNOWN FEMORAL COMPONENT. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT BEGAN EXPERIENCING PAIN APPROXIMATELY 4 YEAR POST IMPLANTATION. X-RAYS SHOWED THE LOCKING SCREW HAD BACKED OUT. THE LINER WAS REVISED 8 MONTHS LATER. IT WAS DISCOVERED THAT THE SCREW HAD BROKEN OFF IN THE STEM AND THE TOP PORTION OF THE SCREW WAS FLOATING IN THE JOINT. IT WAS NOTED THAT THE SCREW WAS REMOVED FROM THE PATIENT'S JOINT AND THE BOTTOM HALF OF THE SCREW REMAINED IN THE STEM EXTENSION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693736 ARTICULAR SURFACE WITH LOCKING SCREW PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 62326587

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R