BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO II HEAD COMPONENT

    MDR report key: 6401339 · Received March 13, 2017

    Report

    Report Number
    0001825034-2017-01525
    Event Type
    Injury
    Date Received
    March 13, 2017
    Date of Event
    February 4, 2017
    Report Date
    July 28, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWL
    PMA / PMN Number
    PK984028
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT ¿ BIOMET ECHO FEMORAL, CATALOG#: 12-150313, LOT #: 907150; ENDO II TAPER ADAPTER CATALOG#: 139248 LOT# 022450 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DEVICE WAS NOT RETURNED SO PRODUCT EVALUATION COULD BE CONDUCTED. THIS DEVICE WAS USED FOR TREATMENT. DEVICE HISTORY REPORT WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED 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 · 1

    IT WAS REPORTED THAT PATIENT HAD A HIP ARTHROPLASTY ONE MONTH POST-IMPLANTATION DUE TO DISLOCATION. THE FEMORAL HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE, BUT NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181690 ENDO II HEAD COMPONENT PROSTHESIS, HIP KWL BIOMET ORTHOPEDICS N/A 366960

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R