BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS

    MDR report key: 8931741 · Received August 26, 2019

    Report

    Report Number
    0001822565-2019-03561
    Event Type
    Injury
    Date Received
    August 26, 2019
    Date of Event
    July 1, 2019
    Report Date
    January 23, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K032726
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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). CONCOMITANT MEDICAL PRODUCTS: CATALOG#: 00625006540 BONE SCR 6.5X40 SELF-TAP LOT#: 64271220. CATALOG#: 00875101240 LINER NEUTRAL 40 MM I.D. LOT#: 64191434. CATALOG#: 00875705601 SHELL WITH CLUSTER HOLES POROUS LOT#: 64004850. CATALOG#: 00877504002 BIOLOX® DELTA, CERAMIC FEMORAL HEAD LOT#: 2901405. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, DUE TO THE DEVICE BEING DISCARDED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 4 MONTHS POST-IMPLANTATION DUE TO PAIN AND OBSERVED STEM SUBSIDENCE. 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
    726226 FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 64189699

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R