BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM NON-FLARED ONE-PIECE CUP 38X56MM

    MDR report key: 2103001 · Received May 25, 2011

    Report

    Report Number
    1825034-2011-00402
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    November 18, 2009
    Report Date
    May 20, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS ORIGINALLY REPORTED ON MANUFACTURER REPORT NUMBER 1825034-2011-00228 WITH MULTIPLE OTHER EVENTS. FURTHER INFORMATION PROVIDED BY SURGEON AND A REVIEW OF INVOICE HISTORY REVEALED THE PRODUCT IDENTIFICATION OF COMPONENT(S) RELATED TO THIS EVENT. ATTEMPTS WERE MADE TO IDENTIFY ALL OF THE EVENTS REPORTED; HOWEVER, NOT ALL EVENTS COULD BE CONFIRMED VIA INVOICE HISTORY. 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: "MATERIAL SENSITIVITY REACTIONS. IMPLANTATION OF FOREIGN MATERIAL IN TISSUES MAY RESULT IN HISTOLOGICAL REACTIONS INVOLVING VARIOUS SIZES OF MACROPHAGES AND FIBROBLASTS." "PARTICULATE WEAR DEBRIS AND DISCOLORATION FROM METALLIC AND POLYETHYLENE COMPONENTS OF JOINT IMPLANTS MAY BE PRESENT IN ADJACENT TISSUE OR FLUID. IT HAS BEEN REPORTED THAT WEAR DEBRIS MAY INITIATE A CELLULAR RESPONSE RESULTING IN OSTEOLYSIS OR OSTEOLYSIS MAY BE A RESULT OF LOOSENING OF THE IMPLANT." (B)(4).

    Additional Manufacturer Narrative · 1

    IN REVIEW, THE JOURNAL ARTICLE IS RELAYING INFORMATION THAT WAS PREVIOUSLY REPORTED IN MDR NUMBERS 1825034-2011-00228 & 1825034-2011-00402/433. THIS REPORT FILED (B)(4), 2011.

    Description of Event or Problem · 1

    BIOMET ORTHOPEDICS RECEIVED VERY PRELIMINARY INFORMATION REGARDING SEVERAL REVISIONS WHICH WERE OUTLINED IN A PRESENTATION CONDUCTED BY A SURGEON AT THE (B)(6). FURTHER INFORMATION PROVIDED BY THE SURGEON AND A REVIEW OF INVOICE HISTORY CONFIRMED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004 AND THAT A SUBSEQUENT REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2009 DUE TO OSTEOLYSIS, METAL SENSITIVITY AND PSEUDOTUMOR. INFORMATION FROM SURGEON INDICATES THAT ONLY THE ACETABULAR CUP WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A 38MM NON-FLARED ONE-PIECE CUP 38X56MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 180910

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R