BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN FEMORAL STEM

    MDR report key: 7273792 · Received February 15, 2018

    Report

    Report Number
    0001822565-2018-00825
    Event Type
    Injury
    Date Received
    February 15, 2018
    Date of Event
    January 16, 2018
    Report Date
    February 26, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE ALSO SEE ASSOCIATED REPORT(S): 0001822565-2018-00824, 0001825034-2018-00907. ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: 00902603400, FEMORAL HEAD 32 MM DIAMETER LONG 14 MM NECK LENGTH, LOT 60017229; 11-103562, UNIV RNGLC SHL 62MM/L24, LOT 176070; 11-105924, ARCOM 32MM RNGLOC LNR HWALL 24, LOT 211880. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO NOT BE REPORTABLE AS WE DO NOT HAVE REPORTING RESPONSIBILITY FOR THIS COMPLAINT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED APPROXIMATELY 15 YEARS POST IMPLANTATION DUE TO PAIN. THE STEM WAS REMOVED, AND THE CUP WAS RETAINED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117535 UNKNOWN FEMORAL STEM PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R