BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MS-30, STEM, STANDARD, CEMENTED, 12, TAPER 12/14

    MDR report key: 11723485 · Received April 26, 2021

    Report

    Report Number
    0009613350-2021-00183
    Event Type
    Injury
    Date Received
    April 26, 2021
    Date of Event
    April 13, 2021
    Report Date
    April 26, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LZO
    PMA / PMN Number
    K040803
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. CONCOMITANT MEDICAL PRODUCT: G7 NEUTRAL E1 LINER 32MM F; CATALOG#: 01.0000.850; LOT#: 6231676. THERAPY DATE: (B)(6) 2021. THE MANUFACTURER RECEIVED OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, 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. ZIMMER BIOMETS REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE AND POST IMPLANTATION STARTED EXPERIENCING RECURRENT DISLOCATIONS. HENCE, PATIENT UNDERWENT A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623674 MS-30, STEM, STANDARD, CEMENTED, 12, TAPER 12/14 HIP PROSTHESIS LZO ZIMMER SWITZERLAND MANUFACTURING GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R