BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM 12/14 NECK TAPER

    MDR report key: 7329411 · Received March 9, 2018

    Report

    Report Number
    0002648920-2018-00171
    Event Type
    Injury
    Date Received
    March 9, 2018
    Date of Event
    February 13, 2018
    Report Date
    March 13, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JDI
    PMA / PMN Number
    PK960658
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE STEM IDENTIFIED DEBRIS ON THE DISTAL PORTION OF THE STEM AND ALSO VISIBLE DEBRIS AROUND THE TAPER OF THE STEM. THERE WERE ALSO SCRATCHES AROUND THE TAPER WHERE IT MATES WITH THE HEAD. 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 ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). CONCOMITANT MEDICAL PRODUCTS: 0100010709, METASUL® ALPHA INSERT, 2464429; 193206, METASUL® HEAD, 2464451; 4245, ALLOFIT SCREWLESS CUP, 2472443. REPORT SOURCE, FOREIGN - THE EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 A PATIENT UNDERWENT AN INITIAL LEFT HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO METALLOSIS. THE PATIENT ALSO HAD A COLLECTION OF FLUID AND PAIN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170089 FEMORAL STEM 12/14 NECK TAPER PROSTHESIS, HIP JDI ZIMMER MANUFACTURING B.V. N/A 60979537

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R