BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 46MM

    MDR report key: 3063872 · Received April 17, 2013

    Report

    Report Number
    0001825034-2013-01034
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    June 13, 2013
    Report Date
    November 24, 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

    EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE IS (OR MAY BE) NEEDED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY. 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. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PERSON (REFERENCE 1825034-2013-01033/ 01034).

    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: "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." AND "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." AND "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 2 OF 4 MDRS FILED FOR THE SAME PERSON (REFERENCE 1825034-2013-01033/-01034 & 2014-04021/-04022).

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 8 STATES, ¿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.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTIES AND REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN A REVIEW OF INVOICE HISTORY CONFIRMS A HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2006 AND ANOTHER HIP ARTHROPLASTY OCCURRED ON (B)(6) 2007. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. 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 THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTIES AND REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN A REVIEW OF INVOICE HISTORY CONFIRMS A HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2006 AND ANOTHER HIP ARTHROPLASTY OCCURRED ON (B)(6) 2007. THERE HAS BEEN NO REPORTED 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'S LEGAL COUNSEL REPORTS PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. LEGAL DOCUMENT FURTHER ALLEGES A LEFT HIP REVISION OCCURRED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, PHYSICAL IMPAIRMENT, DISFIGUREMENT, AND ELEVATED METAL ION LEVELS.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTIES AND REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN A REVIEW OF INVOICE HISTORY CONFIRMS A HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(4) 2006 AND ANOTHER HIP ARTHROPLASTY OCCURRED ON (B)(4) 2007. THERE HAS BEEN NO REPORTED 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'S LEGAL COUNSEL REPORTS PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. LEGAL DOCUMENT FURTHER ALLEGES A LEFT HIP REVISION OCCURRED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, PHYSICAL IMPAIRMENT, DISFIGUREMENT, AND ELEVATED METAL ION LEVELS. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS REVEALED THE LEFT HIP REVISION OCCURRED ON (B)(6) 2013 DUE TO PAIN AND MULTIPLE DISLOCATIONS. THE PATIENT'S OPERATIVE REPORT NOTED CUP WAS POSSIBLY RETROVERTED, AND A SEROMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166157 M2A-MAGNUM MOD HD SZ 46MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 275020

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R