BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLORY HEAD RADIAL POROUS COATED SHELL

    MDR report key: 7546481 · Received May 25, 2018

    Report

    Report Number
    0001825034-2018-03634
    Event Type
    Injury
    Date Received
    May 25, 2018
    Date of Event
    May 4, 2018
    Report Date
    October 12, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    PK921181
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THIS REPORT SHOULD BE VOIDED AS IT WAS DETERMINED TO BE A DUPLICATE OF MFR NUMBER 0001825034-2018-03569.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS- CO-CR MODULAR HEAD COMPONENT # ITEM 163620 LOT 437050, MALLORY HEAD PRESS FIT FEMORAL TAPER STEM # ITEM 11-104109 LOT 562590, RINGLOC ACETABULAR LINER # ITEM 11-105993 LOT 385280. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-03636, 0001825034-2018-03637 AND 0001825034-2018-03638. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND 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 THAT THE PATIENT UNDERWENT REVISION SURGERY 16 YEARS POST INITIAL SURGERY DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387211 MALLORY HEAD RADIAL POROUS COATED SHELL PROSTHESIS HIP LZO ZIMMER BIOMET, INC. N/A 523550

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R