BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASUL, ALPHA INSERT, HOODED, II/32

    MDR report key: 7745979 · Received August 3, 2018

    Report

    Report Number
    0009613350-2018-00752
    Event Type
    Injury
    Date Received
    August 3, 2018
    Report Date
    December 7, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDI
    PMA / PMN Number
    PNA
    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

    IT HAS BEEN REALIZED THAT THIS DEVICE BELONGS TO ASSOCIATED PRODUCTS. THE INCIDENT IS ALREADY REPORTED WITH 0009613350-2018-00751. THEREFOR THIS MDR IS OBSOLETE PLEASE INVALIDATE THIS MDR FROM YOUR SYSTEM. ZIMMER GMBH WILL INVALIDATE THIS MDR FROM THE SYSTEM. ZIMMER REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    UDI#: (B)(4). DETAIL OF PRODUCT: ASSOCIATED ITEM NUMBER: 173206; ITEM NAME: SULOX, HEAD, M¸ 32/0, TAPER 12/14; LOT #: 2460651. ASSOCIATED ITEM NUMBER: 00000004265; ITEM NAME: ALLOFT-S ALLOCLASSIC SHL 52/II; LOT #: 2452071. ASSOCIATED ITEM NUMBER: 290039090; ITEM NAME: CLS SPOTORNO, STEM, 135, UNCEMENTED, 9.0, TAPER 12/14; LOT #: 2437399. THE MANUFACTURER DID NOT RECEIVE X-RAYS, BUT RECEIVED OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. 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. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOW THE IMPLANT THE PATIENT EXPERIENCED 2-3 HIP DISLOCATION, SOLVED BY MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590163 DURASUL, ALPHA INSERT, HOODED, II/32 N/A JDI ZIMMER GMBH N/A 2456420

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R