BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEXLOC +5 SZCX32MM 10DEG M2A

    MDR report key: 2900741 · Received January 8, 2013

    Report

    Report Number
    0001825034-2013-00031
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 10, 2010
    Report Date
    September 20, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION FROM THE PATIENT¿S MEDICAL RECORDS, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 1 OF 5 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-00031 / 00034 & 04723).

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 4, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." NUMBER 15, "POSTOPERATIVE BONE FRACTURE AND PAIN." THIS REPORT IS NUMBER 1 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00031 / 00034). THE 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 RIGHT TOTAL HIP ARTHROPLASTY AND REPORTS PATIENT ALLEGATIONS OF NOISE, INSTABILITY, PAIN, METALLOSIS AND LOSS OF RANGE OF MOTION. REVIEW OF INVOICE HISTORY CONFIRMS THE HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2005. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2010 AND A FURTHER REVISION PROCEDURE PERFORMED ON (B)(6) 2011. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE AND THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2005 TO REMOVE AND REPLACE THE POLYETHYLENE ACETABULAR LINER AND MODULAR HEAD DUE TO POLYETHYLENE WEAR. PATIENT MEDICAL RECORDS FURTHER INDICATE THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2010 DUE TO DISASSOCIATION OF THE ACETABULAR INSERT. REVISION OPERATIVE NOTES FROM (B)(6) 2010 NOTED PRESENCE OF GRAY TINGED FLUID AND CONFIRMED THE ACETABULAR INSERT AND MODULAR HEAD WERE REMOVED AND REPLACED. OPERATIVE NOTES WERE PROVIDED FOR A SUBSEQUENT REVISION PROCEDURE THAT WAS PERFORMED ON (B)(6) 2011. REVISION OPERATIVE NOTES FROM (B)(6) 2011 CONFIRM THE ACETABULAR INSERT AND MODULAR HEAD WERE REMOVED AND REPLACED DUE TO RECURRENT DISLOCATIONS.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY AND REPORTS PATIENT ALLEGATIONS OF NOISE, INSTABILITY, PAIN, METALLOSIS AND LOSS OF RANGE OF MOTION. REVIEW OF INVOICE HISTORY CONFIRMS THE HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2005. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2010 AND A FURTHER REVISION PROCEDURE PERFORMED ON (B)(6) 2011. 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
    9774 HEXLOC +5 SZCX32MM 10DEG M2A PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 937590

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R