BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP

    MDR report key: 3921420 · Received July 9, 2014

    Report

    Report Number
    0001825034-2014-06073
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    September 11, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: EXPIRATION DATE - UNKNOWN; DATE IMPLANTED - UNKNOWN; PMA/510(K) NUMBER; MANUFACTURE DATE ¿ UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY AND A LEFT TOTAL HIP ARTHROPLASTY ON UNKNOWN DATES. SUBSEQUENTLY, PATIENT UNDERWENT RADIOGRAPHS ON (B)(6) 2014 THAT REVEALED A DISLOCATED RIGHT HIP. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY AND A LEFT TOTAL HIP ARTHROPLASTY ON UNKNOWN DATES. SUBSEQUENTLY, PATIENT UNDERWENT RADIOGRAPHS ON (B)(6) 2014 THAT REVEALED A DISLOCATED RIGHT HIP. ADDITIONAL INFORMATION RECEIVED INDICATES PATIENT SUCCESSFULLY UNDERWENT A CLOSED REDUCTION PROCEDURE, AND THE SURGICAL PROCEDURE WAS CANCELLED. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401922 UNKNOWN HIP PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R