BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-T UNIV 2-HOLE SHELL SZ 41/52

    MDR report key: 3140830 · Received May 31, 2013

    Report

    Report Number
    0001825034-2013-01763
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    March 23, 2011
    Report Date
    September 27, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK003363
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY MEDICAL RECORD INFORMATION REGARDING THE REVISION PROCEDURE, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 2 OF 8 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-01762 / 01768 AND -4826).

    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. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "EARLY OR LATE POSTOPERATIVE, INFECTION, AND ALLERGIC REACTION." AND "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 2 OF 7 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-01762 / 01768).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2002 AND THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011 DUE TO PATIENT ALLEGATIONS OF PAIN, DYSFUNCTION, ELEVATED METAL ION LEVELS, LOSS OF RANGE OF MOTION, INSTABILITY, AND INFECTION. PATIENT'S LEGAL COUNSEL FURTHER REPORTED A REVISION PROCEDURE OCCURRED ON (B)(6) 2011 DUE TO ALLEGATION OF DEHISCENCE OF THE LEFT HIP ABDUCTOR MUSCLES AND FACIA. MEDICAL RECORDS REPORT THE PATIENT UNDERWENT A TOTAL LEFT HIP ARTHROPLASTY (B)(6) 2002, WHICH WAS REVISED (B)(6) 2011 DUE TO PAIN. REVISION OPERATIVE NOTES INDICATE PRESENCE OF METALLIC DEBRIS AND SYNOVIAL TISSUE WITH METALLIC STAINING, COMPONENT MALPOSITIONING WITH SUBLUXATION OF THE HIP, AND SURFACE DAMAGE TO THE FEMORAL HEAD. MEDICAL RECORDS ALSO REPORT THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY (B)(6) 2002, WHICH WAS REVISED (B)(6) 2011 DUE METALLIC GRANULOMA AND BONE EROSION. REVISION OPERATIVE NOTES INDICATE DIRTY, BLACKISH FLUID AND METAL-ON-METAL REACTION. THE FEMORAL HEAD AND CUP WERE REMOVED. MEDICAL RECORDS REPORT THE PATIENT UNDERWENT FURTHER REVISION ON (B)(6) 2011 DUE TO A DISLOCATION. 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 THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2002 AND THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011 DUE TO PATIENT ALLEGATIONS OF PAIN, DYSFUNCTION, ELEVATED METAL ION LEVELS, LOSS OF RANGE OF MOTION, INSTABILITY, AND INFECTION. PATIENT'S LEGAL COUNSEL FURTHER REPORTED A REVISION PROCEDURE OCCURRED ON (B)(6) 2011 DUE TO ALLEGATION OF DEHISCENCE OF THE LEFT HIP ABDUCTOR MUSCLES AND FACIA. A REVIEW OF INVOICE HISTORY CONFIRMED THE PRIMARY SURGERY DATE AND THAT TWO ADDITIONAL REVISION PROCEDURES OCCURRED ON (B)(6) 2011 TO REMOVE AND REPLACE THE MODULAR HEADS FOR UNKNOWN REASONS. 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
    242342 M2A-T UNIV 2-HOLE SHELL SZ 41/52 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 003910

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R