BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-METRIC/X POR NC LAT 14X150

    MDR report key: 7213123 · Received January 23, 2018

    Report

    Report Number
    0001825034-2018-00394
    Event Type
    Injury
    Date Received
    January 23, 2018
    Report Date
    October 8, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK020580
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 11-173662, M2A 38 MM MOD HD STD NK, 254250. THE 15-106058, M2A-38 58 MM CUP NON FLARED, 427140. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-00393, 0001825034-2018-00392.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS BEING CONSIDERED FOR A REVISION PROCEDURE DUE TO UNKNOWN REASONS. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57300 BI-METRIC/X POR NC LAT 14X150 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 333790

    Patients

    Seq Age Sex Outcome Treatment
    1 Other