BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP

    MDR report key: 3811796 · Received May 15, 2014

    Report

    Report Number
    0001825034-2014-04001
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    September 18, 2004
    Report Date
    June 17, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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. PRODUCT IDENTIFICATION AND EXPIRATION DATE - UNKNOWN. MANUFACTURE DATE ¿ UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY MAY ALSO CONTRIBUTE TO THESE CONDITIONS." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-04001 /-05727 /-05728).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. PATIENT'S LEGAL COUNSEL REPORTED PATIENT'S ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, DYSFUNCTION, LOSS OF RANGE OF MOTION, ELEVATED METAL ION LEVELS, METAL POISONING, AND METALLOSIS. LEGAL COUNSEL FOR PATIENT FURTHER REPORTED PATIENT UNDERWENT REVISION PROCEDURES ON (B)(6) 2004, AND (B)(6) 2006. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. PATIENT'S LEGAL COUNSEL REPORTED PATIENT'S ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, DYSFUNCTION, LOSS OF RANGE OF MOTION, ELEVATED METAL ION LEVELS, METAL POISONING, AND METALLOSIS. LEGAL COUNSEL FOR PATIENT FURTHER REPORTED PATIENT UNDERWENT REVISION PROCEDURES ON (B)(6) 2004, AND (B)(6) 2006. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN THE (B)(6) 2004 LEFT HIP REVISION OPERATIVE REPORT NOTED THE REVISION WAS DUE TO DISLOCATION AND THE PRESENCE OF A DEFECT IN THE POSTERIOR WALL AND SCAR TISSUE. THE MODULAR HEAD, ACETABULAR LINER AND LOCKING RING WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN THE (B)(6) 2006 LEFT HIP REVISION OPERATIVE REPORT NOTED THE REVISION WAS DUE TO DISLOCATION AND THE PRESENCE OF CLEAR SEROSANGUINEOUS FLUID, SHORT EXTERNAL ROTATORS NO LONGER PRESENT AND ATTACHED, FLIMSY PSEUDOCAPSULE POSTERIORLY, SCAR TISSUE, SUPERIOR LATERAL DEFORMATION AND WEAR OF THE LINER AND FIBROUS TISSUE. THE MODULAR HEAD AND ACETABULAR LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292047 UNKNOWN HIP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R