BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HD 28MM

    MDR report key: 6842152 · Received September 5, 2017

    Report

    Report Number
    0001825034-2017-06585
    Event Type
    Injury
    Date Received
    September 5, 2017
    Date of Event
    October 14, 2015
    Report Date
    December 1, 2017
    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
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). CONCOMITANT MEDICAL PRODUCT: STRYKER ADM ARTICULATING INSERT. REPORTED EVENT WAS ABLE TO BE CONFIRMED VIA REVISION OPERATIVE NOTES. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT PRODUCTS: US157848, M2A MAGNUM CUPS, 614520, 650-1065, CER OPTION TYPE 1 TPR SLEVE -3, 540630, X180307, BI-METRIC/X POR NC 7X115, 222780. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 06586.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY THREE MONTHS POST-IMPLANTATION DUE TO INSTABILITY. DURING THE PROCEDURE, FLUID IN THE BURSAL AREA WAS NOTED. THE FEMORAL HEAD, ACETABULAR CUP AND COMPETITOR BEARING WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622581 CER BIOLOXD OPTION HD 28MM PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 512780

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R