BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-POLY 40MM +3 HIWALL LNR SZ24

    MDR report key: 9662205 · Received February 3, 2020

    Report

    Report Number
    0001825034-2020-00469
    Event Type
    Injury
    Date Received
    February 3, 2020
    Date of Event
    January 10, 2020
    Report Date
    May 19, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    OIY
    UDI-DI
    00880304468962
    PMA / PMN Number
    K100048
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION PROVIDED BY THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE IS 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 ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: PM0002776 ¿ TRIFLANGE CUP ¿ 874690, 00877704004 ¿ BIOLOX DELTA HEAD ¿ 2947414, UNKNOWN APR STEM ¿ UNKNOWN PART AND LOT. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR THE INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. 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 THAT PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 1 MONTH POST IMPLANTATION DUE TO INFECTION. THE HEAD AND LINER COMPONENTS 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
    123637 E-POLY 40MM +3 HIWALL LNR SZ24 PROSTHESIS, HIP OIY ZIMMER BIOMET, INC. N/A 832510 00880304468962

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R