BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CANNULATED SCREW

    MDR report key: 5627355 · Received May 3, 2016

    Report

    Report Number
    0001822565-2016-01403
    Event Type
    Injury
    Date Received
    May 3, 2016
    Date of Event
    September 15, 2014
    Report Date
    April 6, 2016
    Manufacturer
    ZIMMER, INC.
    Product Code
    HWC
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED PRODUCTS ARE MANUFACTURED ZIMMER BIOMET INC., NOT RTI AS PREVIOUSLY REPORTED. THERE WAS NO PRODUCT RETURNED; THEREFORE, NO PHYSICAL EVALUATION COULD BE CONDUCTED. DEVICE HISTORY RECORDS AND COMPLAINT HISTORY COULD NOT BE REVIEWED DUE TO LACK OF PRODUCT IDENTIFICATION; THE LOT NUMBER REQUIRED FOR RETRIEVAL WAS UNAVAILABLE. THIS DEVICE IS USED FOR TREATMENT. THE INVESTIGATION COULD NOT IDENTIFY OR VERIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. THIS COMPLAINT COULD NOT BE CONFIRMED. BASED ON THE AVAILABLE INFORMATION, ROOT CAUSE COULD NOT BE DETERMINED AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED PRODUCTS ARE MANUFACTURED BY (B)(4). ZIMMER BIOMET'S INVESTIGATION IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT HAD A IRRIGATION AND DEBRIDEMENT PROCEDURE FOR FLUID COLLECTION AND LEFT HIP BURSA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283916 UNKNOWN CANNULATED SCREW JDP HWC ZIMMER, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R