BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-METRIC HAP 13X145 MM

    MDR report key: 9283752 · Received November 6, 2019

    Report

    Report Number
    3002806535-2019-00845
    Event Type
    Injury
    Date Received
    November 6, 2019
    Date of Event
    October 24, 2019
    Report Date
    March 18, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D10, G4, H2, H3, H6, H10. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. IN ADDITION, WE HAVE NOT BEEN PROVIDED WITH X-RAYS OR ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS REPORTED. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 2 YEARS HAS FOUND NO SIMILAR COMPLAINTS REPORTED WITH THESE ITEMS. 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

    IT WAS REPORTED THAT AFTER INITIAL SURGERY, THE PATIENT PRESENTED WITH RAISED COBALT LEVEL IN THEIR BLOOD. THE PATIENT IS NOW BEING MONITORED.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN EVENT OCCURRED IN THE (B)(6). CONCOMITANT MEDICAL PRODUCTS: M2A 1 PC SHELL 38MMX52MM, CATALOG #: 15-105052, LOT #: 607040; M2A 38MM MOD HD STD NK, CATALOG #: 11-173662, LOT #: 069820. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER INITIAL SURGERY, THE PATIENT PRESENTED WITH RAISED COBALT LEVEL IN THEIR BLOOD. THE PATIENT IS NOW BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1081384 BI-METRIC HAP 13X145 MM HIP PROSTHESIS JDI BIOMET UK LTD. N/A 1491657

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization