BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER OPTION TYPE 1 TPR SLEVE +6

    MDR report key: 9165892 · Received October 8, 2019

    Report

    Report Number
    3002806535-2019-00812
    Event Type
    Injury
    Date Received
    October 8, 2019
    Date of Event
    July 4, 2019
    Report Date
    October 25, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 THAT PATIENT UNDERWENT PRIMARY LEFT THA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ORTHOSTATIC HYPOTENSION AND THIS DELAYED THE PATIENTS DISCHARGE FROM THE HOSPITAL. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: CER BIOLOXD OPTION HD 40MM CATALOG #: 650-1058 LOT #: 2982740. ASSOCIATED DEVICES MEDICAL PRODUCT: TPRLC 133 T1 PPS HO 13X146MM CATALOG #: 51-104130 LOT #: 6498655, MEDICAL PRODUCT: G7 PPS LTD ACET SHELL 60G CATALOG #: 010000667 LOT #: 6555005, MEDICAL PRODUCT: G7 NEUTRAL E1 LINER 40MM G CATALOG #: 010000865 LOT #: 6233683. REMAINS IMPLANTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00811. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCTS IN THE PROCESS OF BEING RETURNED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY LEFT THA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ORTHOSTATIC HYPOTENSION AND THIS DELAYED THE PATIENTS DISCHARGE FROM THE HOSPITAL. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961250 CER OPTION TYPE 1 TPR SLEVE +6 HIP PROSTHESIS LZO BIOMET UK LTD. N/A 2959195

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization