BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-METRIC LAT PC 14X150MM (T1)

    MDR report key: 5239241 · Received November 20, 2015

    Report

    Report Number
    3002806535-2015-04096
    Event Type
    Injury
    Date Received
    November 20, 2015
    Date of Event
    December 11, 2013
    Report Date
    November 11, 2015
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    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 THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET FRANCE AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN WARSAW, INDIANA MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K030055. PRODUCT WAS RETURNED TO ZIMMER BIOMET; HOWEVER, PRODUCT WAS EVALUATED BY AN EXTERNAL SITE. EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. ROOT CAUSE OF THE EVENT WAS MOST LIKELY ATTRIBUTED TO THIRD PARTY DEBRIS, PATIENT ANATOMY OR SURGICAL TECHNIQUE; HOWEVER, A CONCLUSIVE DETERMINATION COULD NOT BE MADE. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS." NUMBER 10 STATES, "FRETTING AND CREVICE CORROSION CAN OCCUR AT INTERFACES BETWEEN COMPONENTS." NUMBER 11 STATES, "WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES." UNDER WARNINGS AND PRECAUTIONS, NUMBER 3 STATES, "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS." NUMBER 4 STATES, "MALALIGNMENT OF COMPONENTS OR INACCURATE IMPLANTATION CAN LEAD TO EXCESSIVE WEAR AND/OR FAILURE OF THE IMPLANT OR PROCEDURE." THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 3002806535-2014-00010 & 3002806535-2015-04085 / 04086 & 04096).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HOSPITAL THAT THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2011 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2013 DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769058 BI-METRIC LAT PC 14X150MM (T1) PROSTHESIS, HIP LPH BIOMET UK LTD. N/A 2121291

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R