BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOX DELTA HEAD,

    MDR report key: 7591551 · Received June 12, 2018

    Report

    Report Number
    0001825034-2018-03917
    Event Type
    Injury
    Date Received
    June 12, 2018
    Date of Event
    May 15, 2018
    Report Date
    February 18, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    PK082996
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS 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.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORTING.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS DISCARDED. CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: 51-104090, ITEM NAME: TAPERLOC STEM, ITEM NUMBER: 6191176, ITEM NUMBER: 650-1067, ITEM NAME: CER OPTION TAPER ADAPTOR, ITEM NUMBER: 2920601, ITEM NUMBER: EP-200148, ITEM NAME: ACTIVE ARTICULATION E1 POLY CUP, ITEM NUMBER: 236460. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 03918, 0001825034 - 2018 - 03916. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN INITIAL HIP PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO LEG LENGTH DISCREPANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434721 CER BIOLOX DELTA HEAD, PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 2909256

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R