BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CERAMIC HEAD

    MDR report key: 13659359 · Received March 3, 2022

    Report

    Report Number
    0009613350-2022-00122
    Event Type
    Injury
    Date Received
    March 3, 2022
    Date of Event
    February 27, 2019
    Report Date
    June 14, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LZO
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE YET, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. 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).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A CERAMIC HEAD WAS IMPLANTED ON (B)(6) 2014 AND REVISED ON (B)(6) 2020 DUE TO HETEROTOPIC OSSIFICATION. THIS EVENT OCCURRED DURING THE PMCF STUDY ON THE GTS STEM. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. DEVICE IS USED FOR TREATMENT. INSUFFICIENT INFORMATION PROVIDED. UNABLE TO PERFORM A COMPATIBILITY CHECK. COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: FEMORAL HEAD REVISION (DELTA CERAMIC HEAD) DUE TO HETEROTOPIC OSSIFICATION. THE EVENT WAS REPORTED BY DR ROSSI DURING THE PMCF STUDY ON THE GTS STEM.

    Description of Event or Problem · 0

    NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1683064 DELTA CERAMIC HEAD HIP PROSTHESIS LZO ZIMMER SWITZERLAND MANUFACTURING GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R