BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM 26MM RINGLOC LINER HIWALL 22

    MDR report key: 3032403 · Received April 3, 2013

    Report

    Report Number
    0001825034-2013-00842
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    November 28, 2012
    Report Date
    March 7, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK970501
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    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: "PARTICULATE WEAR DEBRIS AND DISCOLORATION FROM METALLIC OR POLYETHYLENE COMPONENTS OF JOINT IMPLANTS MAY BE PRESENT IN ADJACENT TISSUE OR FLUID. IT HAS BEEN REPORTED THAT THIS WEAR DEBRIS MAY INITIATE A CELLULAR PROCESS RESULTING IN OSTEOLYSIS OR IT MAY BE PRESENT AS A RESULT OF LOOSENING OF THE IMPLANT."

    Description of Event or Problem · 1

    PATIENT REPORTED TO HAVE UNDERGONE TOTAL HIP ARTHROPLASTY ON (B)(6) 2002 AND THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO ALLEGED LYTIC LESION AS A RESULT OF THE POLYETHYLENE LINER. A REVIEW OF INVOICE HISTORY FOUND THE PRIMARY SURGERY OCCURRED ON (B)(6) 2002. AN INVOICE FOR THE REVISION PROCEDURE COULD NOT BE OBTAINED. PATIENT REPORTED THAT THE POLYETHYLENE LINER WAS REMOVED AND REPLACED DURING THE REVISION ALONG WITH REMOVAL OF SCREWS. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135841 ARCOM 26MM RINGLOC LINER HIWALL 22 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 375330

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R