BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULAR SURFACE WITH LOCKING SCREW

    MDR report key: 9495559 · Received December 19, 2019

    Report

    Report Number
    0001822565-2019-05363
    Event Type
    Injury
    Date Received
    December 19, 2019
    Report Date
    February 10, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K960279
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS RECEIVED. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: INTERVAL DEVELOPMENT OF ABNORMAL CONTOUR OF THE CONSTRAINING ARTICULATION CONSISTENT WITH BEARING SCREW LOOSENING. NO FRACTURE OR OTHER ABNORMALITY. OVERALL FIT AND ALIGNMENT ARE MAINTAINED. THE BONES ARE OSTEOPENIC. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL 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.

    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: 00-5994-014-91 62359895 LCCK FEM IMPLANT SZ D-L, 00-5990-033-20 62178466 PRC AGMT BLOCK DIST SZ C 10MM. REPORT SOURCE: FOREIGN COUNTRY: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAS BEEN INDICATED FOR REVISION DUE TO LOOSENING OF THE LCCK PE SCREW; HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1289118 ARTICULAR SURFACE WITH LOCKING SCREW PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 61766375

    Patients

    Seq Age Sex Outcome Treatment
    1 Other