BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 46MM

    MDR report key: 3792347 · Received May 6, 2014

    Report

    Report Number
    0001825034-2014-03614
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    March 8, 2007
    Report Date
    July 8, 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

    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 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 1825034-2014-03614 / 03615).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 1 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03614 / -03615 AND -06125 / -06126).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006 AND THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2007 TO REPLACE THE MODULAR HEAD. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A SUBSEQUENT REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, BONE/TISSUE DAMAGE, LOSS OF RANGE OF MOTION AND ELEVATED METAL ION LEVELS. A REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL SURGERY DATE; HOWEVER, INVOICES LOCATED FOR THE REVISION PROCEDURES INDICATE THE FIRST REVISION OCCURRED ON (B)(6) 2007 AND THE SECOND REVISION OCCURRED ON (B)(6) 2013. INVOICE HISTORY SUGGESTS THE MODULAR HEAD, TAPER INSERT AND FEMORAL STEM WERE REMOVED AND REPLACED DURING THE FIRST REVISION PROCEDURE. INVOICE HISTORY FURTHER SUGGESTS THAT THE ACETABULAR CUP, MODULAR HEAD AND TAPER INSERT WERE REMOVED AND REPLACED WITH COMPETITOR ACETABULAR COMPONENTS AND A BIOMET CERAMIC HEAD DURING THE SECOND REVISION PROCEDURE. 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 LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006 AND THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2007 TO REPLACE THE MODULAR HEAD. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A SUBSEQUENT REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, BONE/TISSUE DAMAGE, LOSS OF RANGE OF MOTION AND ELEVATED METAL ION LEVELS. A REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL SURGERY DATE; HOWEVER, INVOICES LOCATED FOR THE REVISION PROCEDURES INDICATE THE FIRST REVISION OCCURRED ON (B)(6) 2007 AND THE SECOND REVISION OCCURRED ON (B)(6) 2013. INVOICE HISTORY SUGGESTS THE MODULAR HEAD, TAPER INSERT AND FEMORAL STEM WERE REMOVED AND REPLACED DURING THE FIRST REVISION PROCEDURE. INVOICE HISTORY FURTHER SUGGESTS THAT THE ACETABULAR CUP, MODULAR HEAD AND TAPER INSERT WERE REMOVED AND REPLACED WITH COMPETITOR ACETABULAR COMPONENTS AND A BIOMET CERAMIC HEAD DURING THE SECOND REVISION PROCEDURE. 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 (B)(6) 2007 REPORTS PATIENT WAS REVISED DUE TO PAIN AND LEG LENGTH DISCREPANCY. REVISION OP REPORT NOTES A CRACK WAS OBSERVED IN THE MEDIAL PORTION OF THE NECK EXTENDING LESS THAN 1 CM. ADDITIONAL INFORMATION RECEIVED FROM PATIENT OP NOTES DATED (B)(6) 2013 REPORTS THE PRESENCE OF FLUID CONSISTENT WITH METALLOSIS, SOFT TISSUE STAINING WITH A LAYER OF FIBROUS TISSUE, AND PROXIMAL FEMORAL OSTEOLYSIS. REVISION OP NOTES ALSO REPORT THE CUP WAS ABDUCTED AND ANTEVERTED AND THERE WERE 3 CAVITARY BONE LOSS AREAS STAINED WITH METAL TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272108 M2A-MAGNUM MOD HD SZ 46MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 427480

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R