BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD MOD HD 32MM STD NK

    MDR report key: 9160822 · Received October 7, 2019

    Report

    Report Number
    0001825034-2019-04446
    Event Type
    Injury
    Date Received
    October 7, 2019
    Date of Event
    August 13, 2019
    Report Date
    December 26, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K042091
    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.

    Description of Event or Problem · 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). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 04447. UDI# (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM #192511 ECHO FEM RED LAT NC LOT# 741870, ITEM #110010243- G7 SHELL ¿LOT#621431, ITEM # 010000848-G7 NEUTRAL LINER-LOT#6148277.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT R HIP REVISION APPROXIMATELY 2 YEARS POST IMPLANTATION AND AGAIN 5 MONTHS LATER DUE TO UNKNOWN REASONS. DURING THE PROCEDURE, THE HEAD AND STEM WERE REMOVED AND REPLACED. 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
    954921 CER BIOLOXD MOD HD 32MM STD NK HIP PROSTESIS LZO ZIMMER BIOMET, INC. NI 117110

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R