BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX OPTION, HEAD, S, 44/-3.0, TAPER 12/14

    MDR report key: 8154383 · Received December 12, 2018

    Report

    Report Number
    0009613350-2018-01200
    Event Type
    Injury
    Date Received
    December 12, 2018
    Date of Event
    November 21, 2014
    Report Date
    June 27, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE PREVIOUS MEDWATCH. THIS COMPLAINT IS A DUPLICATE COMPLAINT OF (B)(4) (REPORTED UNDER THE REFERENCE 0009613350-2017-00198) AND THEREFORE (B)(4) IS BEING SET TO "NOT A COMPLAINT". PLEASE DELETE THIS REPORT FROM YOUR DATABASE. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS A DUPLICATE COMPLAINT OF (B)(4) (REPORTED UNDER THE REFERENCE 0009613350-2017-00198) AND THEREFORE (B)(4) IS BEING SET TO "NOT A COMPLAINT". PLEASE DELETE THIS REPORT FROM YOUR DATABASE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM# 00.151505.444, LOT# 61869990, ITEM: LINER AND SHELL WITH PLASTIC BARRIER 44 MM I.D. 54 MM. ITEM# 00771100900, LOT# 62246921, FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 9. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K073567. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT REMAINS IMPLANTED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED A PAIN TREATMENT APPROXIMATELY ONE YEAR POST IMPLANTATION DUE TO PAIN AND SOME PROBLEMS WITH WALKING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997412 BIOLOX OPTION, HEAD, S, 44/-3.0, TAPER 12/14 N/A LZO ZIMMER GMBH N/A 2698865

    Patients

    Seq Age Sex Outcome Treatment
    1 Other