BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MLRY-HD LAT POR FEMORAL 15MM

    MDR report key: 2635846 · Received June 29, 2012

    Report

    Report Number
    0001825034-2012-00984
    Event Type
    Injury
    Date Received
    June 29, 2012
    Date of Event
    June 14, 2011
    Report Date
    June 30, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATE, "MATERIAL SENSITIVITY REACTIONS." NUMBER 14 STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN." 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 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00984-1 / 00986-1).

    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. THE STEM REMAINS IMPLANTED AND WAS NOT REVISED AS PREVIOUSLY REPORTED.

    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. THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00984 / 00986). THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THERE ARE NO ALLEGATIONS AGAINST THIS DEVICE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT PATIENT UNDERWENT M2A HIP ARTHROPLASTY ON (B)(6) 2004. SUBSEQUENTLY, IT IS ALLEGED THAT THE PATIENT WAS REVISED ON (B)(6) 2011, FOR AN UNKNOWN REASON. 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 ARTHROPLASTY AND REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN MEDICAL NOTES AND A REVIEW OF INVOICE HISTORY CONFIRMS THE HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2004. SUBSEQUENTLY, IT IS ALLEGED THAT THE PATIENT WAS REVISED ON (B)(6) 2011 DUE TO PATIENT ALLEGATIONS OF PAIN, GRATING SENSATION, SQUEAKING AND ELEVATED COCR LEVELS. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MLRY-HD LAT POR FEMORAL 15MM PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 203570

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R