BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP SHELL COCR PC DIA48/42MM

    MDR report key: 4123255 · Received September 26, 2014

    Report

    Report Number
    3002806535-2014-00212
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 11, 2014
    Report Date
    December 11, 2015
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    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 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS." NUMBER 11 STATES, "WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES." NUMBER 27 STATES, "WEAR AND CORROSION OF THE METAL COMPONENTS CAN CAUSE AN ¿ADVERSE LOCAL TISSUE REACTION (ALTR)¿ OR AN ¿ADVERSE REACTION TO METAL DEBRIS (ARMD)¿, WHICH CAN DAMAGE THE SURROUNDING BONE AND SOFT TISSUES." 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 3002806535-2014-00212 & 00213).

    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. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. EXPIRATION DATE - UNKNOWN; MANUFACTURE DATE - UNKNOWN. THIS IS 1 OF 2 REPORTS BEING SUBMITTED FOR THE SAME EVENT. ALSO SEE: 3002806535-2014-00213.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP RESURFACING PROCEDURE ON (B)(6) 2008. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO ARMD AND A MECHANICAL COMPLICATION OF THE INTERNAL JOINT PROSTHESIS. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602485 RECAP SHELL COCR PC DIA48/42MM PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 109639

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R