BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 CUP NON FLARED SZ 56MM

    MDR report key: 3528971 · Received December 19, 2013

    Report

    Report Number
    0001825034-2013-06158
    Event Type
    Injury
    Date Received
    December 19, 2013
    Date of Event
    November 28, 2013
    Report Date
    December 22, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF MANUFACTURING HISTORY FOUND NO EVIDENCE OF PRODUCT NON-COMFORMANCE. ALL MATING FEATURES OF BOTH COMPONENTS WERE MEASURED AND ALL DIMENSIONS WERE WITHIN PRINT SPECIFICATION. DUE TO THIS, IT IS PROBABLE THAT THE COMPONENTS WERE CONFORMING WHEN THEY LEFT BIOMET CONTROL. ADDITIONALLY ROOT CAUSE ANALYSIS CAN NOT BE DETERMINED AS NO OUT-OF-SPECIFICATIONS WERE FOUND. REVIEW OF IFU 01-50-0960 SHOWS UNDER POSSIBLE ADVERSE EFFECTS NUMBER 15 THAT, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES. ALTHOUGH MECHANICAL TESTING DEMONSTRATES THAT METAL-ON-METAL ARTICULATING SURFACES PRODUCE A RELATIVELY LOW AMOUNT OF PARTICLES, THE TOTAL AMOUNT OF PARTICULATE PRODUCED IN VIVO THROUGHOUT THE SERVICE LIFE OF THE IMPLANTS REMAINS UNDETERMINED. THE LONG-TERM BIOLOGICAL EFFECTS OF THE PARTICULATE AND METAL IONS ARE UNKNOWN." THE REVISION PROCEDURE THAT OCCURRED ON (B)(6), 2013 WAS REPORTED ON (B)(6), 2013 ON MEDWATCH NUMBER 0001825034-2013-06158. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-02888 AND 0001825034 - 2013-06158-1.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CORRECTION: CHROMIUM LEVEL RESULTS HAVE BEEN CORRECTED IN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2013 DUE TO PAIN AND ELEVATED METAL ION LEVELS. IT WAS FURTHER REPORTED THAT THE SURGEON NOTED FLUID AND A PSEUDOTUMOR DURING THE REVISION PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2013 DUE TO PAIN AND ELEVATED METAL ION LEVELS. IT WAS FURTHER REPORTED THAT THE SURGEON NOTED FLUID AND A PSEUDOTUMOR DURING THE REVISION PROCEDURE. ADDITIONAL INFORMATION RECEIVED REPORTS ADVERSE REACTION TO METAL DEBRIS (ARMD) WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665164 M2A-38 CUP NON FLARED SZ 56MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 640050

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R