BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-POLY 36MM +3 HIWALL LNR SZ23

    MDR report key: 6900212 · Received September 28, 2017

    Report

    Report Number
    0001825034-2017-07495
    Event Type
    Injury
    Date Received
    September 28, 2017
    Date of Event
    August 23, 2017
    Report Date
    September 28, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK090103
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). CONCOMITANT MEDICAL PRODUCTS: 36MM COCR MOD HD -6MM P/N 11-363660 L/N 100820, R/B RLOC LHOLE SHL 50MM SZ 23 P/N 11-106050 L/N 187730, TAPERLOC POR RED/DIST 12.5X145 P/N 12-103206 L/N 137540, TI LOW PROFILE SCREW 6.5X20MM P/N 103531 L/N 219360, TI LOW PROFILE SCREW 6.5X25MM P/N 103532 L/N 668790, TI LOW PROFILE SCREW 6.5X25MM P/N 103532 L/N 668790. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. RADIOGRAPHIC EVALUATION NOTED EVIDENCE OF POSSIBLE POLYETHYLENE WEAR, OSTEOLYSIS, RADIOLUCENCY, AND POSSIBLE ACETABULAR CUP AND SCREW LOOSENING. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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 · 1

    IT WAS REPORTED THE PATIENT WAS REVISED DUE TO INSTABILITY. OSTEOLYSIS, CUP LOOSENING AND LINER WEAR, WERE NOTED FROM PROVIDED X-RAYS. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680471 E-POLY 36MM +3 HIWALL LNR SZ23 HIP PROSTHESIS JDI ZIMMER BIOMET, INC. N/A 908570

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R