BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP

    MDR report key: 5406391 · Received February 3, 2016

    Report

    Report Number
    0001825034-2016-00329
    Event Type
    Injury
    Date Received
    February 3, 2016
    Date of Event
    May 7, 2004
    Report Date
    January 12, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. (B)(4). EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED.  SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 11 STATES, ¿WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES.¿ THIS REPORT IS NUMBER 12 OF 12 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-00816-3 / 2014-03248-2 / 2014-03249-3 / 2014-03250-3 / 03251-3 / 2014-03252-2 / 2014-03253-2 / 2014-03254-2 / 2014-03255-2 / 2014-03256-2 / 2014-3261-2 / 2016-00329).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY ON (B)(6) 1992. PATIENT UNDERWENT A RIGHT REVISION PROCEDURE ON (B)(6), 2008 DUE TO POLY WEAR, OSTEOLYSIS AND PAIN. DURING THE PROCEDURE, THE HEAD AND ACETABULAR COMPONENTS WERE REMOVED AND REPLACED. IT WAS FURTHER REPORTED PATIENT UNDERWENT A RIGHT RADICAL DEBRIDEMENT PROCEDURE ON (B)(6), 2009 DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACER. PATIENT WAS REIMPLANTED ON THE RIGHT SIDE ON (B)(6), 2009. SUBSEQUENTLY, PATIENT UNDERWENT A RIGHT REVISION ON (B)(6), 2010 DUE TO PAIN, RECURRENT DISLOCATION AND LEG LENGTH SHORTENING. DURING THE PROCEDURE, THE LINER AND HEAD WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED REPORTED PATIENT UNDERWENT A LEFT REVISION ON (B)(6), 2003 DUE TO POLY WEAR. PATIENT UNDERWENT ANOTHER LEFT REVISION ON (B)(6), 2004 DUE TO UNKNOWN MECHANICAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65672 UNKNOWN HIP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R