BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAN/BUR RNGLC SHELL 56MM SZ 24

    MDR report key: 3871105 · Received June 13, 2014

    Report

    Report Number
    0001825034-2014-05460
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    January 14, 2011
    Report Date
    June 3, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK911685
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "MATERIAL SENSITIVITY REACTIONS.¿ AND "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." AND "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." AND "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 6 OF 7 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03302/ -03305, -05456, AND -05460 / -05461).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004 AND LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, INFLAMMATION, BONE AND TISSUE DAMAGE, LOSS OF RANGE OF MOTION, METAL POISONING, METALLOSIS AND ELEVATED METAL ION LEVELS. LEGAL COUNSEL REPORTED THAT A RIGHT HIP REVISION PROCEDURE TOOK PLACE ON (B)(6) 2013 AND A LEFT HIP REVISION PROCEDURE TOOK PLACE ON (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 FROM PATIENT OPERATIVE (OP) NOTES DATED NOVEMBER 16, 2006 REPORTS THE PATIENT WAS REVISED ON THE LEFT HIP DUE TO PAIN AND INSTABILITY. REVISION OP NOTES REPORT A LOOSE STEM WITH FIBROUS INGROWTH, AND ACETABULAR COMPONENT WAS VERTICAL AND RETROVERTED. THE CUP, HEAD, AND STEM WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT OP NOTES DATED (B)(6) 2011 REPORTS THE PATIENT UNDERWENT A SECOND REVISION ON THE LEFT HIP DUE TO ASEPTIC LOOSENING. REVISION OP NOTES REPORT THE PRESENCE OF RUBBERY, FIBROUS TISSUE IN THE MARROW CAVITY IN THE INTERSPACES OF THE TRABECULAR BONE; LOOSE CUP AND LINER; ANTERIOR TROCHANTERIC OSTEOPHYTE; AND ANTERIOR IMPINGEMENT. THE HEAD, LINER AND CUP WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT OP NOTES DATED (B)(6) 2013 REPORTS THE PATIENT WAS REVISED ON THE RIGHT HIP DUE TO IMPINGEMENT. REVISION OP NOTES REPORT THE PRESENCE OF OSTEOLYTIC SYNOVITIS IN SUB-BURSAL AREA AND IMPINGEMENT OF THE TROCHANTER. OP REPORT ALSO NOTES NO SIGNIFICANT FLUID COLLECTION WAS OBSERVED. THE HEAD AND STEM WERE REMOVED AND REPLACED. THE CUP WAS REMOVED AND REPLACED WITH A COMPETITOR COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350922 RAN/BUR RNGLC SHELL 56MM SZ 24 PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 345610

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR