BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP SHELL COCR PC 52/46MM

    MDR report key: 3774048 · Received April 25, 2014

    Report

    Report Number
    3002806535-2014-00115
    Event Type
    Injury
    Date Received
    April 25, 2014
    Date of Event
    February 10, 2014
    Report Date
    September 2, 2014
    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
    NL
    Reporter Occupation
    OTHER

    Narratives

    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. THIS IS 1 OF 2 MDR REPORTS SUBMITTED FOR THE SAME EVENT. SEE ALSO: 3002806535-2014-00116. ITEMS ARE TO BE RETURNED FOR EVALUATION. UPON RETURN OF ITEMS AND COMPLETION OF EVALUATION, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING HISTORY RECORDS FOR ITEM 157852 (LOT 1094007) 52/46MM RECAP SHELL AND ITEM 157246 (LOT 906738) WERE CHECKED AND IT IS REPORTED THAT THE COMPONENTS WERE MANUFACTURED CORRECTLY. IMAGING AND RADIOGRAPHS WERE ALSO SUPPLIED FOR ASSESSMENT. THE RADIOGRAPHS WERE ASSESSED AND THE INCLINATION WAS MEASURED AS BEING APPROXIMATELY 54°, THE ANTEVERSION WAS ESTIMATED TO BE 22° FROM THE MRI. IT SHOULD BE NOTED IN THIS INSTANCE THAT THE SURGICAL TECHNIQUE PROVIDED WITH THE RECAP ACETABULAR SHELL SPECIFIES A RECOMMENDED ORIENTATION WHICH HAS AN INCLINATION ANGLE OF 45° AND ANTEVERSION OF 20°. THE PRODUCT LITERATURE DESCRIBES A CORRELATION BETWEEN HIGH INCLINATION ANGLE OF THE ACETABULAR SHELL, THE RESULTING EDGE LOADING AND INCREASED WEAR. NO PRODUCT HAS BEEN RETURNED FOR EVALUATION AND NO EXACT CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HOSPITAL THAT THE PATIENT UNDERWENT A RESURFACING HIP PROCEDURE ON (B)(6) 2005 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2014 DUE TO ELEVATED METAL ION LEVELS. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HOSPITAL THAT THE PATIENT UNDERWENT A RESURFACING HIP PROCEDURE ON (B)(6) 2005 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2014 DUE TO ELEVATED METAL ION LEVELS. NO FURTHER INFORMATION HAS BEEN RECEIVED. ADDITIONAL INFORMATION RECEIVED: THE COMPONENTS WERE IMPLANTED IN A (B)(6) PATIENT (B)(6)TALL WEIGHING (B)(6), GIVING A BMI OF (B)(6). THE PATIENT HAD INCREASING METAL ION LEVELS WITH A DETECTION OF A FLUID FILLED PSEUDOTUMOR ON THE (B)(6) 2012 BY (B)(6). THE PATIENT ALSO REPORTED MARKED SERIOUS LIMITATIONS OF ACTIVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252236 RECAP SHELL COCR PC 52/46MM PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 1094007

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R