BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-METRIC FEMORAL STEM

    MDR report key: 7647985 · Received June 28, 2018

    Report

    Report Number
    0001825034-2018-04329
    Event Type
    Injury
    Date Received
    June 28, 2018
    Date of Event
    October 18, 2017
    Report Date
    December 10, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MEH
    PMA / PMN Number
    PK020580
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS NOT RETURNED BY PATIENT'S ATTORNEY. MEDICAL DEVICES: ITEM NUMBER: 11-173665, ITEM NAME: M2A FEMORAL HEAD, LOT NUMBER: 042190, ITEM NUMBER: RD118860, ITEM NAME: M2A ACETABULAR CUP, LOT NUMBER: 777390. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 04327 , 0001825034 - 2018 - 04328. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT EXPERIENCED EXCESSIVE BLOOD LOSS DURING REVISION SURGERY REQUIRING IV FLUIDS AND BLOOD PRODUCTS. IT WAS NOTED THE SURGERY REQUIRED ADDITIONAL TIME DUE TO PATIENT'S MORBID OBESITY. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489035 BI-METRIC FEMORAL STEM PROSTHESIS, HIP MEH ZIMMER BIOMET, INC. N/A 689691

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention