BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCEED ABT E1 FLNG CUP 28X48MM

    MDR report key: 8521725 · Received April 17, 2019

    Report

    Report Number
    3002806535-2019-00370
    Event Type
    Injury
    Date Received
    April 17, 2019
    Date of Event
    January 15, 2019
    Report Date
    July 17, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (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 · 0

    THE NATIONAL JOINT REGISTRY REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO DISLOCATION AND SUBLUXATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: NOT BIOMET UK MANUFACTURED PRODUCTS MEDICAL PRODUCT:28MM DIAMETER +3.5MM NECK LENGTH, CATALOG #:8018-28-03, LOT #:63630380 , MEDICAL PRODUCT:CPT HIP STEM 12/14 SIZE 0105MM STD, CATALOG #: 8114-00, LOT #: 63693534. REPORT SOURCE: (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    HIP REVISION DUE TO DISLOCATION AND SUBLUXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315080 EXCEED ABT E1 FLNG CUP 28X48MM HIP PROSTHESIS JDI BIOMET UK LTD. N/A 6379407

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R