BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HD 40MM

    MDR report key: 9184257 · Received October 14, 2019

    Report

    Report Number
    3002806535-2019-00815
    Event Type
    Injury
    Date Received
    October 14, 2019
    Date of Event
    August 25, 2019
    Report Date
    March 18, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868248597
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. IN ADDITION, WE HAVE NOT BEEN PROVIDED WITH X-RAYS OR ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS REPORTED. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND 2 SIMILAR COMPLAINTS REPORTED WITH THE ITEM. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. 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

    PATIENT UNDERWENT PRIMARY LEFT THA. SUBSEQUENTLY, THE PATIENT EXPERIENCED A DISLOCATION AND CLOSED REDUCTION WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). REMAINS IMPLANTED. CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: G7 HI-WALL E1 LINER 40MM I CATALOG #: 010000945 LOT #: 6046200, MEDICAL PRODUCT: G7 PPS LTD ACET SHELL 66I CATALOG #: 010000670 LOT #: 6275966, MEDICAL PRODUCT: TPRLC 133 T1 PPS SO 22X164MM CATALOG #: 51-103220 LOT #: 6143346, MEDICAL PRODUCT: CER OPT TYPE 1 TPR SLEVE 0MM CATALOG #: 650-1066 LOT #: 2959127. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT PRIMARY LEFT THA. SUBSEQUENTLY, THE PATIENT EXPERIENCED LEFT THA DISLOCATION AND CLOSED REDUCTION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978901 CER BIOLOXD OPTION HD 40MM HIP PROSTHESIS LZO BIOMET UK LTD. N/A 2982812 00887868248597

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization SEE H10