BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM DIA TI MOD HEAD ION STD NK

    MDR report key: 6778094 · Received August 9, 2017

    Report

    Report Number
    0001825034-2017-06197
    Event Type
    Injury
    Date Received
    August 9, 2017
    Date of Event
    July 11, 2017
    Report Date
    December 22, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZY
    PMA / PMN Number
    PK915548
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT(S): 104302 704990 ACET LNR H-WALL 28MM ID SZ B. 103507 564860 TI ACET SCREW 5.0X40MM. 103511 655230 TI ACET SCREW 6.5 X 25MM. 103507 635090 TI ACET SCREW 5.0X40MM. 103512 546610 TI ACET SCREW 6.5 X 30MM. 103554 664250 UNIV HEXLC SHL 54MM B. 162313 582950 BI-METRIC PC 13X145MM T1. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 06190.

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED ON THIS FORM WAS PREVIOUSLY SUBMITTED UNDER MANUFACTURING REPORT NUMBER 0001825034-2017-03387.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT¿S HIP WAS REVISED APPROXIMATELY 29 YEAR POST-IMPLANTATION DUE TO INSTABILITY DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561437 28MM DIA TI MOD HEAD ION STD NK PROSTHESIS, HIP LZY BIOMET ORTHOPEDICS N/A 608560

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R