BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM RNGLC LNR 22MM HWALL 22

    MDR report key: 3790056 · Received May 5, 2014

    Report

    Report Number
    0001825034-2014-03574
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    June 28, 2011
    Report Date
    June 11, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK926107
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03574 & 05868).

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 11 STATES, "WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2001. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2011 DUE TO POLYETHYLENE WEAR. ALL COMPONENTS WERE REMOVED AND REPLACED. PATIENT UNDERWENT A FURTHER REVISION PROCEDURE ON (B)(6) 2014 DUE TO INSTABILITY AND POLYETHYLENE WEAR.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2001. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2011 DUE TO POLY WEAR. FUTURE REVISION HAS BEEN INDICATED DUE TO INSTABILITY. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269412 ARCOM RNGLC LNR 22MM HWALL 22 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 993280

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R