BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HEAD SZ 46MM

    MDR report key: 3790785 · Received May 5, 2014

    Report

    Report Number
    0001825034-2014-03578
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 1, 2013
    Report Date
    July 30, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    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 11 STATES, "WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES." NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN."

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION. THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-03578, 05682 AND 05683).

    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.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2006, AND A TOTAL LEFT HIP ARTHROPLASTY ON (B)(6) 2008. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A RIGHT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF BALANCE AND METAL WEAR. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO THE LEFT HIP. A REVIEW OF INVOICE HISTORY CONFIRMED BOTH INITIAL SURGERY DATES AND THE RIGHT HIP REVISION SURGERY DATE. INVOICE HISTORY FURTHER CONFIRMED THE MODULAR HEAD AND TAPER INSERT WERE REMOVED AND REPLACED WITH AN ACTIVE ARTICULATION LINER AND MODULAR HEAD DURING THE RIGHT HIP REVISION. 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 TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2006, AND A TOTAL LEFT HIP ARTHROPLASTY ON (B)(6) 2008. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A RIGHT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF BALANCE AND METAL WEAR. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO THE LEFT HIP. A REVIEW OF INVOICE HISTORY CONFIRMED BOTH INITIAL SURGERY DATES AND THE RIGHT HIP REVISION SURGERY DATE. INVOICE HISTORY FURTHER CONFIRMED THE MODULAR HEAD AND TAPER INSERT WERE REMOVED AND REPLACED WITH AN ACTIVE ARTICULATION LINER AND MODULAR HEAD DURING THE RIGHT HIP REVISION. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE REPORT NOTED PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2013 DUE TO PAIN. REVISION OPERATIVE REPORT NOTED THICKENING OF THE CAPSULE AND NO EVIDENCE OF METALLOSIS, TRUNNION WEAR OR IMPINGEMENT OF THE TRUNNION. THE MODULAR HEAD AND TAPER INSERT WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2006, AND A TOTAL LEFT HIP ARTHROPLASTY ON (B)(6) 2008. LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2013, DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF BALANCE, AND METAL WEAR. TO DATE, THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO THE LEFT HIP. A REVIEW OF INVOICE HISTORY CONFIRMED BOTH DATES AND THAT THE MODULAR HEAD WAS 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
    266748 M2A-MAGNUM MOD HEAD SZ 46MM PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 400190

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R