BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM 12/14 NECK TAPER EXT. OFFSET SIZE 2 130 MM STEM LENGTH

    MDR report key: 9217594 · Received October 22, 2019

    Report

    Report Number
    0002648920-2019-00756
    Event Type
    Injury
    Date Received
    October 22, 2019
    Date of Event
    October 11, 2019
    Report Date
    January 8, 2020
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JDI
    PMA / PMN Number
    K960658
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. RADIOGRAPHS WERE RECEIVED, HOWEVER THE COMPLAINT WAS UNABLE TO BE CONFIRMED. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING : RIGHT TOTAL HIP ARTHROPLASTY WITH VARUS POSITIONING OF THE FEMORAL STEM AND POSSIBLE EVIDENCE OF ASPETIC LOOSENING OF THE STEM. THERE WAS RADIOLUCENCY ALONG THE BONE CEMENT INTERFACE OF THE FEMORAL STEM. NO OTHER ABNORMALITIES WERE IDENTIFIED. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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: UNKNOWN CERAMIC LINER LOT#103574, UNKNOWN FEMORAL HEAD LOT#331579. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO THE DEVICE BEING DISCARDED BY THE HOSPITAL. 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 A PATIENT UNDERWENT A REVISION PROCEDURE DUE TO ASEPTIC LOOSENING. 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
    1012106 FEMORAL STEM 12/14 NECK TAPER EXT. OFFSET SIZE 2 130 MM STEM LENGTH PROSTHESIS, HIP JDI ZIMMER MANUFACTURING B.V. N/A 61401568

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R