BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERAMIC BIOLOXD OPTION HEAD 36MM

    MDR report key: 7629364 · Received June 22, 2018

    Report

    Report Number
    0001825034-2018-04197
    Event Type
    Injury
    Date Received
    June 22, 2018
    Date of Event
    April 22, 2018
    Report Date
    August 2, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    PK082996
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO THE FACT THE PATIENT FLEXED THE HIP SO MUCH THAT THE HEAD DISLOCATED FROM THE LINER. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO REMAINING IN THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 010000859, G7 NEUTRAL E1 LINER 36MM G, 6227063, 193014, ECHO B-MTRC MP FP SO 14, 785800, 010000666, G7 PPS LTD ACET SHELL 58G, 6232582. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 04196.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT SUFFERED DISLOCATION APPROXIMATELY 3 WEEKS POST IMPLANTATION. PATIENT WAS REACHING FOR SOMETHING ON THE FLOOR WHILE SITTING ON A LOW STOOL. DISLOCATION WAS CORRECTED WITH CLOSED REDUCTION WITH THE PATIENT UNDER GENERAL ANESTHESIA. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470771 CERAMIC BIOLOXD OPTION HEAD 36MM HIP PROSTHESIS LZO ZIMMER BIOMET, INC. N/A 2907287

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention