BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP O/SZ SHELL COCR PC 56/48

    MDR report key: 5538944 · Received March 31, 2016

    Report

    Report Number
    3002806535-2016-00161
    Event Type
    Injury
    Date Received
    March 31, 2016
    Date of Event
    February 29, 2016
    Report Date
    March 4, 2016
    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
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. 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. THIS REPORT IS 2 OF 2 MDRS FOR THE SAME EVENT (REFERENCE 3002806535-2016-00161 & 00162).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, AN ACETABULAR REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2016 DUE TO ELEVATED METAL ION LEVELS. DURING THE PROCEDURE, THE FEMORAL STEM WAS REMOVED AFTER THE SURGEON COULD NOT DETACH THE TAPER ADAPTER. IT WAS FURTHER REPORTED THAT DURING REPLACEMENT OF THE FEMORAL STEM, THE SURGEON CHOSE TO USE CEMENT ON THE DISTAL PORTION OF AN UNCEMENTED STEM DESPITE BEING FAMILIAR WITH THE SURGICAL TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193772 RECAP O/SZ SHELL COCR PC 56/48 PROSTHESIS, HIP KWA BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R