BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAGNER CONE PROSTHESIS, 135, UNCEMENTED, 19, TAPER 12/14

    MDR report key: 15256592 · Received August 19, 2022

    Report

    Report Number
    0009613350-2022-00425
    Event Type
    Injury
    Date Received
    August 19, 2022
    Date of Event
    July 27, 2022
    Report Date
    September 8, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LZO
    UDI-DI
    00889024480834
    PMA / PMN Number
    K113556
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: G7 OSSEOTI 3 HOLE SHELL 50MM D ITEM# 110010243 LOT# 65346043; G7 VIT E NEUTRAL LNR 36MM D ITEM# 30103604 LOT# 65338039; BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH ITEM# 00625006530 LOT# J7263653; BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH ITEM# 00625006530 LOT# J7263667; BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 36/-3.5, TAPER 12/14 ITEM# 00877503601 LOT# 3111466; CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH ITEM# 00223200418 LOT# 64927345. 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.

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED A MEDWATCH REPORT SHOULD NOT HAVE BEEN FILED UNDER THE CURRENT MANUFACTURER AS THE CONCERNED PRODUCT IS NOT ZIMMER SWITZERLAND MANUFACTURING GMBH DESIGN CONTROL. THE EVENT WILL BE FURTHER REPORTED BY ZIMMER INC. GIVEN THIS INFORMATION, THIS MEDWATCH WILL BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FEMUR FRACTURED WHILE IMPLANTING CONE STEM. CABLES WERE USED TO FIX THE FRACTURE INTRAOPERATIVELY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    THE DEVICE PREVIOUSLY REPORTED ON THIS MEDWATCH IS NOT RELATED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2791574 WAGNER CONE PROSTHESIS, 135, UNCEMENTED, 19, TAPER 12/14 PROSTHESIS, HIP, SEMI-CONSTRAINED LZO ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3095394 00889024480834

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H SEE H10 NARRATIVE