BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 54ODX48ID

    MDR report key: 3970539 · Received July 31, 2014

    Report

    Report Number
    0001825034-2014-06651
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    February 15, 2011
    Report Date
    October 27, 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
    NY, 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.

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. IT WAS INITIALLY REPORTED THAT A REVIEW OF THE INVOICE HISTORY CONFIRMED THE INITIAL SURGERY DATE; HOWEVER, INVOICE HISTORY SHOWS INITIAL PROCEDURE OCCURRED (B)(6) 2009.

    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 WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - (B)(6) 2011; DATE EXPLANTED - (B)(6)2011. 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, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ NUMBER 15 STATES, ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES.¿ 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 EVENT (REFERENCE 1825034-2014-06651 & 06652).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN, LACK OF MOBILITY, DAMAGE TO BONE/TISSUE, METAL POISONING, METALLOSIS AND ELEVATED METAL ION LEVELS. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNKNOWN DATE. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE INITIAL SURGERY DATE; HOWEVER, AN INVOICE COULD NOT BE LOCATED TO CONFIRM THE REVISION PROCEDURE AND WHICH COMPONENTS WERE REMOVED AND REPLACED. 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) 2009. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, DYSFUNCTION, SWELLING, INFLAMMATION, LACK OF MOBILITY, LOSS OF RANGE OF MOTION, DAMAGE TO BONE/TISSUE, METAL POISONING, METALLOSIS AND ELEVATED METAL ION LEVELS. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL ALLEGED PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNKNOWN DATE IN (B)(6)2011. A REVIEW OF THE INVOICE HISTORY SHOWS AN INITIAL HIP PROCEDURE OCCURRED (B)(6) 2009; HOWEVER, THERE WAS NO RECORD FOUND FOR THIS PATIENT FOR (B)(6) 2009. IN ADDITION, AN INVOICE COULD NOT BE LOCATED TO CONFIRM THE REVISION PROCEDURE AND WHICH COMPONENTS WERE REMOVED AND REPLACED. 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 MEDICAL RECORDS CONFIRMED THE RIGHT HIP ARTHROPLASTY PROCEDURE WAS PERFORMED ON (B)(6) 2009 AND THE REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011. FURTHER INFORMATION IN PATIENT'S MEDICAL RECORDS REVEAL THE REVISION WAS DUE TO TORN EXTERNAL ROTATOR TENDONS, AND SCAR TISSUE FORMATION. THE PATIENT'S OPERATIVE REPORT NOTED SCAR TISSUE, A DEHISCENCE OF THE IT BAND, AND DETACHMENT OF THE EXTERNAL ROTATORS FROM THE GREATER TROCHANTER.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, DYSFUNCTION, SWELLING, INFLAMMATION, LACK OF MOBILITY, LOSS OF RANGE OF MOTION, DAMAGE TO BONE/TISSUE, METAL POISONING, METALLOSIS AND ELEVATED METAL ION LEVELS. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL ALLEGED PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2011. A REVIEW OF THE INVOICE HISTORY SHOWS AN INITIAL HIP PROCEDURE OCCURRED (B)(6) 2009; HOWEVER, THERE WAS NO RECORD FOUND FOR THIS PATIENT FOR (B)(6) 2009. IN ADDITION, AN INVOICE COULD NOT BE LOCATED TO CONFIRM THE REVISION PROCEDURE AND WHICH COMPONENTS WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448074 M2A-MAGNUM PF CUP 54ODX48ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 346370

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R