BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP PF HA FMRL HD RESUR 46MM

    MDR report key: 3943819 · Received July 18, 2014

    Report

    Report Number
    0001825034-2014-06300
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    September 9, 2012
    Report Date
    October 18, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KXA
    PMA / PMN Number
    PK071053
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.(B)(4)

    Additional Manufacturer Narrative · 1

    CORRECTED & ADDITIONAL INFORMATION: ADDED DATE OF EVENT. EVENT DESCRIPTION ¿ PATIENT WAS NOT ENROLLED IN A CLINICAL STUDY. A RETROSPECTIVE CLINICAL REVIEW IDENTIFIED THE PATIENT¿S EVENT. A CLOSED REDUCTION WAS PERFORMED ON (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THESE TYPES OF EVENTS CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY MAY ALSO CONTRIBUTE TO THESE CONDITIONS." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06300 & 06301).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A RIGHT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2012. DURING POST-OPERATIVE MONITORING, DISLOCATION WAS NOTED ON (B)(6) 2012. THESE FINDINGS WERE FOUND DUE TO FOLLOW UP MONITORING, THERE WERE NO SYMPTOMS REPORTED BY THE PATIENT. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE SURGERY DATE.

    Description of Event or Problem · 1

    AS PART OF A RETROSPECTIVE CLINICAL STUDY, A PATIENT WAS IDENTIFIED WHO UNDERWENT A RIGHT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2012. SUBSEQUENTLY, PATIENT UNDERWENT A CLOSED REDUCTION ON (B)(6) 2012 DUE TO DISLOCATION. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE. ADDITIONAL INFORMATION RECEIVED REVEALED DISLOCATION WAS DUE TO PATIENT PUTTING HIP IN AN EXTREME POSITION. ADDITIONAL INFORMATION RECEIVED REVEALED PATIENT UNDERWENT ANOTHER CLOSED REDUCTION ON (B)(6), 2012 DUE TO DISLOCATION AND SUBSEQUENTLY RECEIVED A BRACE. PATENT HAS BEEN STABLE AT ONE YEAR POST OP.

    Description of Event or Problem · 1

    AS PART OF A RETROSPECTIVE CLINICAL STUDY, A PATIENT WAS IDENTIFIED WHO UNDERWENT A RIGHT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2012. SUBSEQUENTLY, PATIENT UNDERWENT A CLOSED REDUCTION ON (B)(6) 2012 DUE TO DISLOCATION. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421716 RECAP PF HA FMRL HD RESUR 46MM PROSTHESIS, HIP KXA BIOMET ORTHOPEDICS N/A 972960

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R