BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-METRIC HA/PC 7X115MM (T1)

    MDR report key: 2723796 · Received September 1, 2012

    Report

    Report Number
    3002806535-2012-00248
    Event Type
    Injury
    Date Received
    September 1, 2012
    Date of Event
    July 4, 2012
    Report Date
    August 1, 2012
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED ON (B)(6) 2012 CONFIRMING THAT THE REVISED PRODUCT REPORTED IN THIS MEDWATCH WAS MANUFACTURED BY BIOMET UK LTD. REPORT NUMBER 1825034-2012-01464 IS FOR THE REVISED BIOMET ORTHOPEDICS MANUFACTURED PRODUCT AND IS ASSOCIATED WITH THIS PATIENT/EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012. THE REASON FOR THE REVISION IS UNKNOWN. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BI-METRIC HA/PC 7X115MM (T1) PROSTHESIS, HIP LPH BIOMET UK LTD. N/A 805301

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R