BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVITAN, PROXIMAL PART, CONICAL, UNCEMENTED, 75, TAPER 12/14

    MDR report key: 8554544 · Received April 26, 2019

    Report

    Report Number
    0009613350-2019-00265
    Event Type
    Malfunction
    Date Received
    April 26, 2019
    Date of Event
    March 30, 2019
    Report Date
    November 19, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    N/A
    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

    THIS DEVICE WILL BE SET AS CONCOMITANT MEDICAL PRODUCT IN MEDWATCH: 0009613350-2019-00266. PLEASE INVALIDATE THIS MEDWATCH FROM YOUR SYSTEM. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM: CABLE CERCLAGE CABLE, CATALOG #: 00223200418, LOT #: 63102417. ITEM: CABLE CERCLAGE CABLE, CATALOG #: 00223200418, LOT #: 63170498. ITEM: CABLE CERCLAGE CABLE, CATALOG #: 00223200418, LOT #: 63102425. ITEM: CABLE CERCLAGE CABLE, CATALOG #: 00223200418, LOT #: 63175472. ITEM: BIOLOX DELTA, CERAMIC HEAD , CATALOG #: 00877504004, LOT #: 2708250. ITEM: REVITAN DISTAL PART, CATALOG #: 0100405326, LOT #: 2611037. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K071723. THE MANUFACTURER DID NOT RECEIVE THE DEVICE YET, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. (B)(4). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2019-00266.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO IMPLANT FRACTURE ON AN UNKNOWN DATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350632 REVITAN, PROXIMAL PART, CONICAL, UNCEMENTED, 75, TAPER 12/14 N/A LZO ZIMMER GMBH N/A 2823920

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R