BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAL ALPHA INSERT NEUTR LL/36

    MDR report key: 8595450 · Received May 9, 2019

    Report

    Report Number
    0009613350-2019-00283
    Event Type
    Injury
    Date Received
    May 9, 2019
    Date of Event
    March 22, 2019
    Report Date
    July 8, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDI
    PMA / PMN Number
    N/A
    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 FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE PREVIOUS MEDWATCH. IT WAS DISCOVERED THAT THIS COMPLAINT (B)(4) IS A DUPLICATE OF THE ORIGINAL (B)(4) (SUBMITTED UNDER THE REFERNCE 0009613350-2019-00263). BOTH COMPLAINTS REPORT THE SAME ISSUE/EVENT, EVENT DATE:(B)(6) 2019, IMPLANT DATE:(B)(6) 2019, EXPLANT DATE:(B)(6) 2019, ITEM #: 01.00013.712 LOT #: 2973010, HOSPITAL NAME:(B)(6), SURGEON NAME:DR. (B)(6), PATIENT: (B)(6). FOR THIS REASON, THIS EVENT WILL BE COVERED IN ORIGINAL COMPLAINT (B)(4) AND (B)(4) WILL BE SET TO "NOT A COMPLAINT" IN OUR DATABASE. PLEASE DELETE THIS REPORT FROM YOUR DATABASE. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    IT WAS DISCOVERED THAT THIS COMPLAINT (B)(4). IS A DUPLICATE OF THE ORIGINAL (B)(4) (SUBMITTED UNDER THE REFERNCE 0009613350-2019-00263). BOTH COMPLAINTS REPORT THE SAME ISSUE/EVENT, EVENT DATE:(B)(6) 2019, IMPLANT DATE:(B)(6) 2019, EXPLANT DATE:(B)(6) 2019, ITEM #: 01.00013.712 LOT #: 2973010, HOSPITAL NAME:(B)(6), SURGEON NAME:DR. (B)(6), PATIENT: (B)(6). FOR THIS REASON, THIS EVENT WILL BE COVERED IN ORIGINAL COMPLAINT (B)(4) AND (B)(4) WILL BE SET TO "NOT A COMPLAINT" IN OUR DATABASE. PLEASE DELETE THIS REPORT FROM YOUR DATABASE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM# 01.00013.712, LOT# 2973010, DURAL ALPHA INSERT NEUTR LL/36. ITEM# 4248, LOT# 2972430, ALLOFIT ALLOCLASSIC SHL 58/LL. PREMARKET IDENTIFICATION: 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 K013935. DEVICE EVALUATED BY MANUFACTURER: 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 LOT NUMBER OF THE DEVICE WAS RECEIVED. THE DEVICE HISTORY RECORDS WILL BE REVIEWED DURING INVESTIGATION. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD REVISION SURGERY APPROXIMATELY 17 DAYS POST IMPLANTATION DUE TO LOOSENING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387218 DURAL ALPHA INSERT NEUTR LL/36 NA JDI ZIMMER GMBH N/A 2973010

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R