BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR FMRL 9X137

    MDR report key: 5599430 · Received April 22, 2016

    Report

    Report Number
    0001825034-2016-01386
    Event Type
    Injury
    Date Received
    April 22, 2016
    Date of Event
    September 12, 2007
    Report Date
    March 8, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK921301
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED DUE TO THE PART/LOT INFORMATION COULD BE: LOT NUMBER - 506420; EXPIRATION DATE - DEC 31, 2015; MANUFACTURE DATE ¿ JAN 2, 2006. OR THE PART/LOT INFORMATION COULD BE: LOT NUMBER - 915150; EXPIRATION DATE - MAR 31, 2015; MANUFACTURE DATE ¿ APR 4, 2005. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES, ¿LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY.¿ THIS REPORT IS NUMBER 6 OF 6 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-07630 / 2014-07631 / 2015-04975 / 2014-07632 / 2016-01385 / 2016-01386). PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTIES ON (B)(6) 2006. SUBSEQUENTLY, THE LEFT HIP WAS REVISED ON (B)(6) 2007 DUE TO AN UNKNOWN REASON. THE MODULAR HEAD AND FEMORAL STEM WERE REMOVED AND REPLACED. IT WAS FURTHER REPORTED THAT A SECOND LEFT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 IN WHICH THE MODULAR HEAD, ACETABULAR CUP AND ACETABULAR LINER WERE REMOVED AND REPLACED DUE TO ELEVATED METAL ION LEVELS. DURING THE REVISION THE PATIENT'S PELVIS WAS FRACTURED, WHICH RESULTED IN THE IMPLANTATION OF A TRICORTICAL BONE WEDGE. THIS CAUSED A DELAY OF APPROXIMATELY 60 MINUTES. SUBSEQUENTLY, A THIRD REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO THE FRACTURE IN THE PATIENT'S PELVIS NOT HEALING. DURING THE REVISION, THE MODULAR HEAD, ACETABULAR CUP AND LINER WERE REMOVED AND REPLACED WITH A BIOMET HEAD AND COMPETITOR CUP AND LINER. ADDITIONAL INFORMATION RECEIVED FROM PATIENT'S LEGAL COUNSEL REPORTED THE PATIENT'S RIGHT HIP WAS REVISED ON (B)(6) 2015 DUE TO PAIN. ELEVATED METAL ION LEVELS AND METALLOSIS WERE ALLEGEDLY NOTED DURING THE PROCEDURE. SUBSEQUENTLY, THE PATIENT DISLOCATED ON (B)(6) 2015. IT IS UNKNOWN HOW THIS EVENT WAS RESOLVED. ADDITIONAL INFORMATION RECEIVED IN OPERATIVE REPORT NOTED THAT DURING THE (B)(6) 2014 REVISION, METAL DEBRIS WITH LARGE CYST FORMATION WAS NOTED. OPERATIVE REPORT FOR THE REVISION ON (B)(6) 2015 NOTED SIGNIFICANT FLUID COLLECTION AND METALLOSIS. THE PROCEDURE WAS COMPLETED WITH COMPETITOR PRODUCT. ADDITIONAL INFORMATION RECEIVED IN OPERATIVE REPORT NOTED THAT THE REVISION PROCEDURE ON (B)(6) 2007 OCCURRED DUE TO PAIN AN LOOSENING OF THE FEMORAL COMPONENT. ADDITIONALLY, DURING THE (B)(6) 2014 REVISION PROCEDURE, IT WAS NOTED THAT NO SIGNS OF METALLOSIS OR INFECTION WERE FOUND. MRI SHOWED SIGNS OF EXCESS FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253280 TAPERLOC POR FMRL 9X137 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R