BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BGS PLATELET SEPARATION SYSTEM

    MDR report key: 7072778 · Received November 30, 2017

    Report

    Report Number
    0001825034-2017-10735
    Event Type
    Injury
    Date Received
    November 30, 2017
    Date of Event
    February 6, 2017
    Report Date
    February 15, 2018
    Manufacturer
    .
    Product Code
    LXG
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW, THIS EVENT WAS CONFIRMED TO BE CAUSED BY PRODUCTS OTHER THAN ZIMMER BIOMET PRODUCTS.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD (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 AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

    PREVIOUS SUBMISSION STATING NOT RELATED TO ZIMMER BIOMET PRODUCTS WAS SENT IN ERROR. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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

    (B)(4). INITIAL REPORTER: JOSEPH E. BROYLES, M. ADAIRE O¿BRIEN, STEPHANIE T. BROYLES AND M. PATRICK STAGG ¿BIOLOGIC AUGMENTED MICRODRILLING SURGERY FOR MULTIPLE AND LARGE FULL-THICKNESS CARTILAGE LESIONS IN THE KNEE: EARLY CLINICAL AND RADIOLOGICAL RESULTS¿ SURGICAL SCIENCE, 2017, 8, 102-117 HTTP://WWW.SCIRP.ORG/JOURNAL/SS. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBERS ARE UNKNOWN. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT ONE PATIENT REPORTED EXPERIENCING SEVERE PAIN AT LAST FOLLOW-UP, FOLLOWING BIOLOGIC AUGMENTED MICRODRILLING SURGERY FOR SYMPTOMATIC CARTILAGE DEFECTS OF THE KNEE. RESOLUTION IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT ONE PATIENT HAD REPORTED SEVERE PAIN AFTER THE PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851972 BGS PLATELET SEPARATION SYSTEM EQUIPMENT, LABORATORY, GENERAL PURPOSE LXG . N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other