BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLOFT-S ALLOCLASSIC SHL 52/II

    MDR report key: 8412192 · Received March 12, 2019

    Report

    Report Number
    0009613350-2019-00118
    Event Type
    Malfunction
    Date Received
    March 12, 2019
    Date of Event
    August 27, 2018
    Report Date
    May 23, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDI
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B4, G4, G7, H10. ADDITIONAL: H2. IT HAS BEEN REALIZED THAT THIS CASE IS A DOUBLE ENTRY. THE INCIDENT IS ALREADY REPORTED WITH (B)(4). THEREFORE THIS MDR IS OBSOLETE. PLEASE INVALIDATE THE CASE FROM YOUR SYSTEM. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    SEE H10.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM# 01.00013.509, LOT# 2920752, DURAL ALPHA INSERT W RIM II/32. ITEM# 00-8018-032-02, LOT# 64065896, FEMORAL HEAD STERILE, 12/14 TAPER. ITEM# 00-8114-000-10, LOT# 63895896, CPT 12/14 SIZE 0 COCR EXT. PMA/510K: 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 K003758. DEVICE EVALUATED BY MFR: THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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). THE FOLLOWING REPORT IS ASSOCIATED WITH THIS EVENT: 0009613350-2019-00119.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY APPROXIMATELY FIVE MONTHS POST IMPLANTATION WHEREBY A TEMPORARY CEMENTED STEM AND CUP WAS IMPLANTED TO TREAT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205318 ALLOFT-S ALLOCLASSIC SHL 52/II N/A JDI ZIMMER GMBH N/A 2920056

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE