BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHP HUDSON ZIMMER ADAPTOR

    MDR report key: 8525978 · Received April 18, 2019

    Report

    Report Number
    3002806535-2019-00377
    Event Type
    Malfunction
    Date Received
    April 18, 2019
    Date of Event
    March 23, 2019
    Report Date
    August 19, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE 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

    REAMING SET HAS FUNCTIONAL ISSUES PREVENTING USE. COMPETITOR'S INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: ACETABULAR RMR DRIVER 12 INCH , CATALOG #: 31-600057, LOT #: NOT REPORTED. REPORT SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00376. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    REAMING SET HAS FUNCTIONAL ISSUES PREVENTING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319668 SHP HUDSON ZIMMER ADAPTOR ORTHOPEDIC MANUAL SURGICAL INSTRUMENT HTO BIOMET UK LTD. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1