BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CERAMIC OPTION HEAD DIA3 6

    MDR report key: 7441060 · Received April 18, 2018

    Report

    Report Number
    0001825034-2018-02791
    Event Type
    Injury
    Date Received
    April 18, 2018
    Date of Event
    February 13, 2017
    Report Date
    August 19, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    PK082996
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE CERAMIC HEAD IDENTIFIED BLACK RUBBING MARKS ALL OVER THE HEAD. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4) CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM # EP-108323, E-POLY 36 MM +3 HIWALL LNR SZ23, LOT # 821420. ITEM # 11-103203, TAPERLOC POR LAT FMRL 9X137, LOT # 172200. ITEM # 650-1064, CER OPTION TYPE 1 TPR SLEVE -6, LOT # 231850. REPORT SOURCE: LEGAL NOTIFICATION. REPORTED EVENT WAS CONFIRMED DUE TO MEDICAL RECORDS RECEIVED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE REPORTS HAVE BEEN SUBMITTED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-07952, 0001825034-2017-07953, 0001825034-2017-07954.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 3 YEARS POST IMPLANTATION DUE TO A POLY LINER FRACTURE, METALLOSIS, AND FEMORAL HEAD WEAR. DUE TO THE FRACTURE OF THE POLY LINER, THE FEMORAL HEAD PERMEATED THROUGH THE LINER CAUSING THE HEAD TO WEAR AGAINST THE CUP CAUSING ASYMMETRIC LOCATION OF THE FEMORAL HEAD. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282767 DELTA CERAMIC OPTION HEAD DIA3 6 HIP PROSTHESIS LZO ZIMMER BIOMET, INC. N/A 411390

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R