BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLORY/HEAD ALTERNATE BEARING SHELL

    MDR report key: 6311902 · Received February 8, 2017

    Report

    Report Number
    0001825034-2017-00488
    Event Type
    Injury
    Date Received
    February 8, 2017
    Date of Event
    January 6, 2017
    Report Date
    April 13, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWZ
    PMA / PMN Number
    PK003363
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS REPORT IS 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001825034-2017-00487 ).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION. A REVIEW OF DEVICE HISTORY RECORDS FOUND NO DEVIATIONS OR ANOMALIES. THE COMPONENTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. COMPLAINT HISTORY COULD NOT BE REVIEWED AS THE REASON FOR REVISION WAS NOT PROVIDED. NO MEDICAL RECORDS WERE PROVIDED AND THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION AVAILABLE. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT PRODUCTS: ITEM #162311, BI-METRIC STEM, LOT #741510, ITEM #15-105004, M2A-TAPER LINER, LOT #283530. MULTIPLE MDRS HAVE BEEN FILED FOR THIS EVENT. PLEASE REFERENCE THE ASSOCIATED REPORT - REFERENCE 0001825034-2017-00487-1.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A HIP REVISION PROCEDURE APPROXIMATELY FIFTEEN YEARS POST-IMPLANTATION DUE TO UNKNOWN REASONS. THE HEAD AND CUP WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94306 MALLORY/HEAD ALTERNATE BEARING SHELL HIP PROSTHESIS KWZ BIOMET ORTHOPEDICS N/A 346300

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R