BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM 12/14 NECK TAPER

    MDR report key: 7379456 · Received March 28, 2018

    Report

    Report Number
    0001822565-2018-01799
    Event Type
    Injury
    Date Received
    March 28, 2018
    Date of Event
    February 23, 2016
    Report Date
    May 11, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK032726
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: 00000004244, ALLOFIT ALLOCLASSIC SHL 50/HH, 2802758; 0100013508, DURASUL® ALPHA INSERT HOODED HH/32, 2799327; 00877503201, BIOLOX® DELTA CERAMIC FEMORAL HEAD, 2828924. (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. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS CONFIRMED BASED ON THE X-RAY AND SURGICAL OP NOTES THAT WERE PROVIDED. THE X-RAY REVIEW SHOWED AVULSION FRACTURE OF THE SUPERIOR ASPECT OF THE LEFT GREATER TROCHANTER. DHR WAS REVIEWED AND IDENTIFIED NO DEVIATIONS/ANOMALIES IN THE MANUFACTURING PROCESS. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED WITH THE INFORMATION PROVIDED. 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 THAT THE PATIENT EXPERIENCES PAIN DUE TO AVULSION OF THE TROCHANTER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCES PAIN DUE TO AVULSION OF THE TROCHANTER. ADDITIONAL SUPPORT AND PAIN RELIEF MEDICATION WERE PROVIDED. NO INTERVENTION WAS NECESSARY AT THIS POINT OF TIME. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220467 FEMORAL STEM 12/14 NECK TAPER PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 62765725

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| O