BEUDAMED
    FDA Adverse Event Injury Summary report: N

    #7 PE ZIPLOOP EXT TOGGLELOC

    MDR report key: 8482929 · Received April 4, 2019

    Report

    Report Number
    0001825034-2019-01527
    Event Type
    Injury
    Date Received
    April 4, 2019
    Date of Event
    March 18, 2019
    Report Date
    August 19, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    PMA / PMN Number
    K130033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. NO MEDICAL RECORDS RECEIVED. ROOT CAUSE COULD NOT 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

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 905262, COMPOSITE SCREW, LOT # 152203. REPORT SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 01528.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 2.5 YEARS POST IMPLANTATION, THE PATIENT UNDERWENT A REVISION PROCEDURE OF THE ACL DUE TO UNKNOWN REASONS, SIGNS, OR SYMPTOMS. DURING THE REVISION, IT WAS NOTED THAT THE PATIENT HAD SIGNIFICANT REACTION TO THE SCREW WITH LIQUID ACCUMULATION. THE LIQUID WAS COLLECTED FOR CULTURES, AND THE RESULTS ARE PENDING. THE SCREW WAS REMOVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275334 #7 PE ZIPLOOP EXT TOGGLELOC FASTENER, FIXATION MBI ZIMMER BIOMET, INC. N/A P05287

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R