BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 54ODX48ID

    MDR report key: 3890491 · Received June 24, 2014

    Report

    Report Number
    0001825034-2014-05639
    Event Type
    Injury
    Date Received
    June 24, 2014
    Report Date
    December 3, 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
    FL, 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, ¿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 NUMBER 2 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-05638 / 05641).

    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

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A LEFT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012, 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. THERE HAS BEEN NO RIGHT HIP REVISION PROCEDURE REPORTED TO DATE. REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL RIGHT HIP SURGERY DATE; HOWEVER, IT INDICATES THE INITIAL LEFT HIP SURGERY WAS PERFORMED ON (B)(6) 2008. INVOICE HISTORY FURTHER CONFIRMED THE LEFT HIP REVISION SURGERY DATE AND SUGGESTS THE MODULAR HEAD, TAPER INSERT AND ACETABULAR CUP WERE REMOVED AND REPLACED WITH COMPETITOR ACETABULAR COMPONENTS AND A BIOMET CERAMIC HEAD. 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 LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A LEFT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 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. THERE HAS BEEN NO RIGHT HIP REVISION PROCEDURE REPORTED TO DATE. REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL RIGHT HIP SURGERY DATE; HOWEVER, IT INDICATES THE INITIAL LEFT HIP SURGERY WAS PERFORMED ON (B)(6) 2008. INVOICE HISTORY FURTHER CONFIRMED THE LEFT HIP REVISION SURGERY DATE AND SUGGESTS THE MODULAR HEAD, TAPER INSERT AND ACETABULAR CUP WERE REMOVED AND REPLACED WITH COMPETITOR ACETABULAR COMPONENTS AND A BIOMET CERAMIC HEAD. 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 THE LEFT HIP REVISION PROCEDURE WAS PERFORMED DUE TO ASEPTIC LOOSENING OF THE ACETABULAR CUP, ELEVATED METAL ION LEVELS AND SCIATIC NERVE PALSY. REVISION OPERATIVE NOTES CONFIRMED THAT THE ACETABULAR CUP WAS REMOVED AND REPLACED WITH COMPETITOR ACETABULAR COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367799 M2A-MAGNUM PF CUP 54ODX48ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 072780

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R