BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM COCR MOD HEAD +6MM

    MDR report key: 3821777 · Received May 20, 2014

    Report

    Report Number
    0001825034-2014-04390
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    July 28, 2011
    Report Date
    May 21, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK032396
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    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 ASSOCIATED 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.¿ THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-04388 / 04390).

    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. THIS REPORT IS NUMBER 3 OF 6 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-04388 / -04390, -05356, -05357, AND -05359).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2002 AND A REVISION PROCEDURE ON (B)(6) 2010 DUE TO PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, DYSFUNCTION, LOSS OF RANGE OF MOTION, LACK OF MOBILITY, ELEVATED METAL ION LEVELS, METAL POISONING AND METALLOSIS. LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A FURTHER REVISION PROCEDURE ON (B)(6) 2011 DUE TO PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, AND EFFUSION. A REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL PROCEDURE. INVOICE HISTORY REVEALED THAT PATIENT UNDERWENT REVISION PROCEDURES ON (B)(6) 2010 AND (B)(6) 2011. 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) 2002 AND A REVISION PROCEDURE ON (B)(6) 2010 DUE TO PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, DYSFUNCTION, LOSS OF RANGE OF MOTION, LACK OF MOBILITY, ELEVATED METAL ION LEVELS, METAL POISONING AND METALLOSIS. LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A FURTHER REVISION PROCEDURE ON (B)(6) 2011 DUE TO PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, AND EFFUSION. A REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL PROCEDURE. INVOICE HISTORY REVEALED THAT PATIENT UNDERWENT REVISION PROCEDURES ON (B)(6) 2010 AND (B)(6) 2011. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT'S OPERATIVE (OP) NOTES DATED (B)(6) 2010 REPORTS PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF THE LEFT ACETABULUM AND CHRONIC SYNOVITIS. REVISION OP REPORT NOTES THE LEFT ACETABULAR COMPONENT AND FEMORAL HEAD WERE DISARTICULATED WITH THE FEMORAL HEAD ARTICULATING INTO THE PELVIC WALL. THE CUP AND HEAD WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN PATIENT'S OP NOTES DATED (B)(6) 2011 REPORTS PATIENT WAS REVISED DUE TO LOOSENING OF THE LEFT ACETABULUM. REVISION OP REPORT NOTES THE PRESENCE OF A LOOSE LEFT ACETABULAR COMPONENT, CAVITARY AND CENTRAL DEFECTS, FIBROUS TISSUE, INFLAMMATORY CHANGES, AND POSSIBLE INFECTION. THE HEAD WAS REMOVED AND REPLACED. THE CUP WAS REMOVED AND REPLACED WITH A COMPETITOR PRODUCT. PATIENT RECORDS ALSO REPORT PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY (B)(6) 2002. THERE HAS BEEN NO REPORTED REVISION PROCEDURE FOR THE RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298908 36MM COCR MOD HEAD +6MM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 679390

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R