BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN M2A HIP

    MDR report key: 4861745 · Received June 23, 2015

    Report

    Report Number
    3002806535-2015-00271
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    May 26, 2015
    Report Date
    December 11, 2015
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    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. 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 1 STATES, "MATERIAL SENSITIVITY REACTIONS." 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." NUMBER 5 STATES, "COMPLETE PRECLOSURE CLEANING AND REMOVAL OF BONE CEMENT DEBRIS, METALLIC DEBRIS AND OTHER SURGICAL DEBRIS AT THE IMPLANT SITE IS CRITICAL TO MINIMIZE WEAR OF THE IMPLANT ARTICULAR SURFACES." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 3002806535-2015-00271 & 04184).

    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 PATIENT (REFERENCE 3002806535-2015-00271 & 04124).

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT HAS BEEN RETURNED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: PRODUCT ID - UNKNOWN; DEVICE INFO - UNKNOWN; PMA/510(K) NUMBER ¿ UNKNOWN; MANUFACTURE DATE ¿ UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2002. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2015 DUE TO METALLOSIS AND ELEVATED METAL ION LEVELS. DURING THE PROCEDURE, THE MODULAR HEAD AND ACETABULAR LINER WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405620 UNKNOWN M2A HIP PROSTHESIS, HIP KWA BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R