BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM 12/14 NECK TAPER EXT. OFFSET SIZE 0 105 MM STEM LENGTH

    MDR report key: 7222391 · Received January 26, 2018

    Report

    Report Number
    0002648920-2018-00053
    Event Type
    Injury
    Date Received
    January 26, 2018
    Date of Event
    September 14, 2015
    Report Date
    May 18, 2018
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JDI
    PMA / PMN Number
    PK960658
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT CURRENTLY REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED. FOREIGN COMPLAINT SOURCE, COMPLAINT WAS REPORTED BY (B)(6). CONCOMITANT MEDICAL PRODUCTS: ITEM #: 00-6200-052-00 ITEM NAME: TRILOGY SHELL LOT #: 60790229, ITEM #: 00-6105-050-28 ITEM NAME: TRILOGY LINER LOT #: 60788407, ITEM #: 00-8018-028-05 ITEM NAME: VERSYS FEMORAL HEAD LOT #:60783812.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED SURGEON OPERATIVE NOTES, INDICATING THAT THE PATIENT UNDERWENT A REVISION OF THE RIGHT TOTAL HIP REPLACEMENT DUE TO STEM FRACTURE. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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 PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY 7 YEARS POST-IMPLANT DUE TO STEM FRACTURE. IT WAS ALSO REPORTED THAT PATIENT HAD PAIN AND HAD TO USE A WALKER PRIOR TO REVISION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64982 FEMORAL STEM 12/14 NECK TAPER EXT. OFFSET SIZE 0 105 MM STEM LENGTH PROSTHESIS, HIP JDI ZIMMER MANUFACTURING B.V. N/A 60776230

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R