BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR HEAD S 36/-4 TAPER 12/14

    MDR report key: 12531755 · Received September 27, 2021

    Report

    Report Number
    0009613350-2021-00494
    Event Type
    Injury
    Date Received
    September 27, 2021
    Date of Event
    June 10, 2021
    Report Date
    September 27, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING 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
    AS
    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. MEDICAL PRODUCT: ALLOFIT ALLOCLASSIC SHELL WITH POLAR SCREW PLUG UNCEMENTED 52/II; CATALOG#: 4245; LOT#:3060441. ALLOCLASSIC SL STEM UNCEMENTED 3 TAPER 12/14; CATALOG#: 2843; LOT#: 3038511. THERAPY DATE: (B)(6) 2021. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR 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 BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INCORRECT SIZE OF IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1431378 COCR HEAD S 36/-4 TAPER 12/14 HIP PROSTHESIS JDI ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3044633

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R