BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ML-HD MOD CALC PROX 45C

    MDR report key: 3102548 · Received May 9, 2013

    Report

    Report Number
    0001825034-2013-01327
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    November 15, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK031693
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN. BRAND NAME - UNKNOWN. PRODUCT IDENTIFICATION AND EXPIRATION DATE - UNKNOWN. DATE EXPLANTED - UNKNOWN. MANUFACTURE DATE - UNKNOWN. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED.

    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 4 STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01327 & 0001825034-2013-05397).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT THE PATIENT UNDERWENT M2A HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT ALLEGES A REVISION WAS PERFORMED ON AN UNKNOWN DATE DUE TO PATIENT ALLEGATIONS OF PAIN AND LOOSENING. NO FURTHER INFORMATION HAS BEEN PROVIDED. 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 LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE DUE TO ALLEGED PAIN AND LOOSENING. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2011 WAS DUE TO THE CALCAR STEM LOOSENING. THE OPERATIVE NOTES CONFIRM THAT THE CALCAR STEM, MODULAR HEAD, AND TAPER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203622 ML-HD MOD CALC PROX 45C PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 391970

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R