BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER OPTION TYPE 1 TPR SLEVE -3

    MDR report key: 9259581 · Received October 31, 2019

    Report

    Report Number
    3002806535-2019-00834
    Event Type
    Injury
    Date Received
    October 31, 2019
    Date of Event
    September 15, 2019
    Report Date
    December 19, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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 · 0

    IT WAS REPORTED PATIENT HAD A THA. SUBSEQUENTLY, APPROXIMATELY ONE MONTH AFTER IMPLANTATION THE PATIENT UNDERWENT A REVISION DURING WHICH THE SURGEON IRRIGATED/DEBRIDED FOR POSSIBLE INFECTION AND THEN IMPLANTED THE NEW DEVICES. HEAD, SLEEVE ADAPTER AND LINER REVISED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: CER BIOLOXD OPTION HD 40MM CATALOG #: 650-1058 LOT #: 2982814, MEDICAL PRODUCT: G7 HI-WALL E1 LINER 40MM F CATALOG #: 010000942 LOT #: 6544646, MEDICAL PRODUCT: UNKNOWN STEM CATALOG #: NOT REPORTED LOT #: NOT REPORTED , MEDICAL PRODUCT: UNKNOWN SHELL CATALOG #: NOT REPORTED LOT #: NOT REPORTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00833. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A THA. SUBSEQUENTLY, APPROXIMATELY ONE MONTH AFTER IMPLANTATION THE PATIENT UNDERWENT A REVISION DURING WHICH THE SURGEON IRRIGATED/DEBRIDED FOR POSSIBLE INFECTION AND THEN IMPLANTED THE NEW DEVICES. HEAD, SLEEVE ADAPTER AND LINER REVISED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058925 CER OPTION TYPE 1 TPR SLEVE -3 HIP PROSTHESIS LZO BIOMET UK LTD. N/A 2959047

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R