BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM DIA COCR MOD HEAD -3MM NK

    MDR report key: 3875280 · Received June 16, 2014

    Report

    Report Number
    0001825034-2014-05516
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    November 9, 2007
    Report Date
    July 13, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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, 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".

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES." AND "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 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-05516 /-06396).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT RIGHT METAL-ON-METAL HIP ARTHROPLASTY ON (B)(6), 2003. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2007 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, LOSS OF RANGE OF MOTION, ELEVATED METAL ION LEVELS, METAL POISONING AND METALLOSIS. A REVIEW OF INVOICE HISTORY CONFIRMED BOTH SURGERY DATES; HOWEVER, INVOICE HISTORY REVEALED THAT A METAL-ON-METAL HIP WAS NOT IMPLANTED IN THE PATIENT ON (B)(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 THAT PATIENT UNDERWENT RIGHT METAL-ON-METAL HIP ARTHROPLASTY ON (B)(6) 2003. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2007 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, LOSS OF RANGE OF MOTION, ELEVATED METAL ION LEVELS, METAL POISONING AND METALLOSIS. A REVIEW OF INVOICE HISTORY CONFIRMED BOTH SURGERY DATES; HOWEVER, INVOICE HISTORY REVEALED THAT A METAL-ON-METAL HIP WAS NOT IMPLANTED IN THE PATIENT ON (B)(6) 2003. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE REPORT RECEIVED NOTED PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2007 DUE TO SUBLUXATION AND DISLOCATIONS. OPERATIVE REPORT NOTED THE PRESENCE OF CLEAR YELLOW FLUID AND SCRATCHES ON THE HEAD. THE MODULAR HEAD AND ACETABULAR LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352931 28MM DIA COCR MOD HEAD -3MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 872950

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R