BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLO OPTION, HEAD, XL¸ 36/+7, TAPER 12/14

    MDR report key: 8770657 · Received July 9, 2019

    Report

    Report Number
    0009613350-2019-00424
    Event Type
    Injury
    Date Received
    July 9, 2019
    Date of Event
    May 3, 2017
    Report Date
    February 12, 2020
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    K073567
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. ADDITIONAL: D4, H2, H6. CORRECTION: B4, B5, G4, G7, H10. DHR REVIEW: REF: 00-8777-036-04; LOT: 2842955. YIELD: 40; DELIVERED: 40. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND IS IDENTIFIED. EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH BIOLOX OPTION HEAD ON (B)(6) 2016. PATIENT EXPERIENCED PAIN UPON FOLLOW UP VISIT ON (B)(6) 2017. THE PATIENT IS USING A WALKER. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. CONCLUSION SUMMARY: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH BIOLOX OPTION HEAD ON (B)(6) 2016. PATIENT EXPERIENCED PAIN UPON FOLLOW UP VISIT ON (B)(6) 2017. THE PATIENT IS USING A WALKER. IN VIVO TIME OF DEVICE IS UNKNOWN. THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). HOWEVER, BASED ON THE AVAILABLE INFORMATION, WE WERE NOT ABLE TO IDENTIFY AN EXACT ROOT CAUSE FOR THIS ISSUE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    INVESTIGATION RESULTS ARE NOW AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE X-RAYS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND BEING MONITORED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566203 BIOLO OPTION, HEAD, XL¸ 36/+7, TAPER 12/14 BIOLO OPTION, HEAD, XL¸ 36/+7, TAPER 12/14 LZO ZIMMER GMBH N/A 2842955

    Patients

    Seq Age Sex Outcome Treatment
    1 Other