BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAN/BUR RNGLC SHL 60MM SZ 25

    MDR report key: 3875007 · Received June 16, 2014

    Report

    Report Number
    0001825034-2014-05525
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    October 14, 2008
    Report Date
    July 18, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK911685
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    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. 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.

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." NUMBER 14 STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN." THE FOLLOWING SECTIONS COULD NOT BE COMPLETED DUE TO THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER - 106060, LOT NUMBER - 092160, EXPIRATION DATE - SEP 30, 2013, MANUFACTURE DATE ¿ SEP 24, 2003. OR THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER - 106058, LOT NUMBER - 139360, EXPIRATION DATE - OCT 31, 2013, MANUFACTURE DATE ¿ OCT 6, 2003. 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 A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2002. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTED PATIENT WAS REVISED ON (B)(6) 2004, DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, BONE/TISSUE DAMAGE, ELEVATED METAL ION LEVELS AND METALLOSIS. PATIENT UNDERWENT A FURTHER REVISION PROCEDURE ON (B)(6) 2008 DUE TO AN UNKNOWN REASON. 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 A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2002. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTED PATIENT WAS REVISED ON (B)(6) 2004 DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, BONE/TISSUE DAMAGE, ELEVATED METAL ION LEVELS AND METALLOSIS. PATIENT UNDERWENT A FURTHER REVISION PROCEDURE ON (B)(6) 2008 DUE TO AN UNKNOWN REASON. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE PROCEDURE PERFORMED ON (B)(6) 2002 WAS A REVISION PROCEDURE. REVISION OPERATIVE REPORT NOTED THE ACETABULAR LINER HAD DISASSOCIATED FROM THE ACETABULAR CUP AND THAT THE ACETABULAR CUP WAS LOOSE. DARKENED SYNOVIAL TISSUE WAS REMOVED AND METAL DEBRIS WAS NOTED. OPERATIVE NOTES DID NOT INDICATE THE DATE OF THE INITIAL RIGHT TOTAL HIP ARTHROPLASTY NOR PRODUCT IDENTIFICATION FOR WHAT WAS ORIGINALLY IMPLANTED IN THE PATIENT. ADDITIONAL INFORMATION RECEIVED IN REVISION OPERATIVE NOTES FROM THE REVISION PROCEDURE THAT WAS PERFORMED ON (B)(6) 2004 INDICATES THAT THE REVISION WAS DUE TO ACETABULAR CUP LOOSENING. THE ACETABULAR CUP AND LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353505 RAN/BUR RNGLC SHL 60MM SZ 25 PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 092160

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R