BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ML-HD MOD CALC PROX 34B

    MDR report key: 3895232 · Received June 25, 2014

    Report

    Report Number
    0001825034-2014-05687
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    August 20, 2012
    Report Date
    September 18, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK031693
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    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. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05686 / 05687).

    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. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH (B)(4). THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05686 / 05687).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT WAS REVISED MULTIPLE TIMES ON UNKNOWN DATES. ON (B)(6) 2012, PATIENT UNDERWENT A REVISION PROCEDURE WITH IRRIGATION AND DEBRIDEMENT DUE TO INFECTION. THE POLYETHYLENE LINER AND FEMORAL HEAD WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN OPERATIVE REPORT NOTED PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2012 DUE TO INFECTION. OPERATIVE REPORT FURTHER NOTED PATIENT EXPERIENCED PAIN WITH DIFFICULTY WALKING, FEELING MALAISE, ABDOMINAL PAIN EIGHT DAYS PRIOR TO REVISION PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED MULTIPLE TIMES ON UNKNOWN DATES. ON (B)(6) 2012, PATIENT UNDERWENT A REVISION PROCEDURE WITH IRRIGATION AND DEBRIDEMENT. THE POLYETHYLENE LINER AND FEMORAL HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371933 ML-HD MOD CALC PROX 34B PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 784630

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R