BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM 28MM RLOC LNR 10D/HWL 22

    MDR report key: 4281057 · Received November 26, 2014

    Report

    Report Number
    0001825034-2014-08805
    Event Type
    Injury
    Date Received
    November 26, 2014
    Date of Event
    October 19, 2014
    Report Date
    January 9, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK023357
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    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 RELATED TO THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY MAY ALSO CONTRIBUTE TO THESE CONDITIONS. " THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-08804 /-08805).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO DISLOCATION. THE HEAD AND LINER WERE REMOVED AND REPLACED. IT WAS FURTHER REPORTED PATIENT UNDERWENT REVISION PROCEDURES ON (B)(6) 2014 AND (B)(6) 2014 DUE TO DISLOCATION CAUSED BY PATIENT ANATOMY.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO DISLOCATION. THE HEAD AND LINER WERE REMOVED AND REPLACED. IT WAS FURTHER REPORTED THAT A REVISION HAS BEEN INDICATED FOR DISLOCATION CAUSED BY THE PATIENT¿S ANATOMY; HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767434 ARCOM 28MM RLOC LNR 10D/HWL 22 PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 802610

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R