BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCR 6.5X30 SELF-TAP

    MDR report key: 8645362 · Received May 28, 2019

    Report

    Report Number
    0002648920-2019-00371
    Event Type
    Injury
    Date Received
    May 28, 2019
    Date of Event
    April 2, 2019
    Report Date
    June 24, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    MRA
    PMA / PMN Number
    K934765
    Removal / Correction Number
    N/A
    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 0002648920-2019-00375.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THIS REPORT SHOULD BE VOIDED AS IT WAS DETERMINED TO BE A DUPLICATE OF MFR NUMBER 0002648920-2019-00375.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET G7 SHELL CAT#010000662 LOT#6395394, BIOMET RINGLOC CAT#31-323240 LOT#949630, BIOMET STEM CAT#192808 LOT# 668350, BIOMET TAPER SLEEVE CAT#650-1064 LOT#2955104, BIOMET HEAD CAT#650-1057 LOT#2955098, BIOMET LINER CAT#010000817 LOT#6354149. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT PRIMARY LEFT THA. SUBSEQUENTLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL APPROXIMATELY 2 MONTHS POST IMPLANTATION DUE TO INFECTION WHERE PATIENT UNDERWENT A TWO-STAGE REVISION SECONDARY TO THE PRESENCE OF (B)(6). ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440145 BONE SCR 6.5X30 SELF-TAP PROSTHESIS, HIP MRA ZIMMER MANUFACTURING B.V. N/A 64228001

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R