BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAGNER CONE PROSTHESIS, 135, UNCEMENTED¸ 14, TAPER 12/14

    MDR report key: 12876697 · Received November 26, 2021

    Report

    Report Number
    0009613350-2021-00617
    Event Type
    Malfunction
    Date Received
    November 26, 2021
    Date of Event
    May 29, 2020
    Report Date
    December 15, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LZO
    UDI-DI
    00889024480797
    PMA / PMN Number
    K113556
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. ADDITIONAL: H2, H6. CORRECTION: B4, G3, G6, H10. WHILE CHECKING THE DOCUMENTS IT WAS FOUND THAT THE WINTERTHUR WAGNER STEM REF# 01.00561.314, LOT# 2936141 WAS IMPLANTED DURING THE REVISION SURGERY PERFORMED ON (B)(6) 2020. THE STEM IMPLANTED ON (B)(6) 2020 THAT WAS INVOLVED IN THE REPORTED EVENT IS A PRESS-FIT FEMORAL STEM FROM ZIMMER BIOMET WARSAW, ALREADY COVERED IN SPLIT-CASE (B)(4) AND REPORTED WITH 0001822565-2021-03565. PLEASE INVALIDATE THE CASE FROM YOUR SYSTEM. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 0

    MEDICAL PRODUCT: FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER; CATALOG#: 00-8018-022-30; LOT#: 63452825; UNK-HIP-UNK-LINER; CATALOG#: UNKNOWN; LOT#: UNKNOWN; FEMORAL STEM PRESS-FIT COLLARLESS 12/14 NECK TAPER STANDARD BODY STANDARD NECK OFFSET SIZE 9 100 MM STEM LENGTH CEMENTLESS; CATALOG#: 00-7864-009-00; LOT#: 63456639. THERAPY DATE: (B)(6) 2020. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. 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. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A REVISION DUE TO DISLOCATION AND LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1776848 WAGNER CONE PROSTHESIS, 135, UNCEMENTED¸ 14, TAPER 12/14 WAGNER CONE PROSTHESIS SYSTEM LZO ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2936141 00889024480797

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R