BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M-H SOLID SHELL HA/PC DIA54MM LN24

    MDR report key: 5471029 · Received March 1, 2016

    Report

    Report Number
    3002806535-2016-00085
    Event Type
    Injury
    Date Received
    March 1, 2016
    Date of Event
    January 30, 2016
    Report Date
    March 2, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. THE MANUFACTURING HISTORY WAS NOT PROVIDED FOR REVIEW. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K021403. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: DEVICE INFO - EXPIRATION UNKNOWN. MANUFACTURE DATE ¿ UNKNOWN. REQUESTED BUT NOT RETURNED BY HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2016. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2016 DUE TO INCORRECT POSITION OF THE CUP DURING THE INITIAL PROCEDURE. THE FEMORAL HEAD, ACETABULAR LINER AND CUP WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126555 M-H SOLID SHELL HA/PC DIA54MM LN24 PROSTHESIS, HIP LPH BIOMET UK LTD. N/A 3532043

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R