BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP FLAT PE HC LINER Ø 36 / F

    MDR report key: 5685284 · Received May 27, 2016

    Report

    Report Number
    3005180920-2016-00242
    Event Type
    Injury
    Date Received
    May 27, 2016
    Date of Event
    April 27, 2016
    Report Date
    July 25, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 22 JULY 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION BASED ON THE X-RAYS RECEIVED ON 27 JUNE 2016, AND COMMENTED AS FOLLOWS: BILATERAL CEMENTLESS THA ON A MALE PATIENT OF (B)(6). ON THE LEFT HIP, OBJECT OF THIS REPORT, A HIGHLY CROSS LINKED PE INSERT WAS USED. OSTEOLYTIC SIGNS ARE NOT VERY MARKED ON THE X-RAY, BUT THE SCINTIGRAPHY SHOWS EVIDENCE OF SIGNIFICANT PROBLEMS. ACCORDING TO REPORT, THE PATIENT SUFFERED OF BACK PROBLEMS AND UNDERWENT BACK SURGERIES. THIS FINDING, A SIGNIFICANT WEAR ON A XLPE LINER IS VERY UNUSUAL. THE LINEAR WEAR IS NOT SO EVIDENT BUT DEFINITELY MORE THAN EXPECTED, FOR UNKNOWN REASONS. ETEROTOPIC OSSIFICATIONS ARE VISIBLE ON BOTH SIDES. LEG LENGTH DISCREPANCY WAS PROBABLY PRESENT AFTER SECOND SURGERY. EXPLANTS, IN PARTICULAR PE INSERT, SHOULD BE ANALYZED IN ORDER TO VERIFY IF THEY WERE CORRECTLY AND FULLY INSERTED IN THE SHELL, BECAUSE A SIGNIFICANT POSSIBILITY IS BACKSIDE WEAR DUE TO NOT-FULLY-SEATED LINERS, WHICH WOULD BE COMPATIBLE WITH THE ABNORMAL REACTION TO A RATHER LIMITED LINEAR WEAR VISIBLE ON X-RAYS. SAME COMMENTS APPLY FOR BOTH HIPS.

    Additional Manufacturer Narrative · 1

    THE PATIENT HAS PAIN AND PROBABLY A SECOND SURGERY WILL BE PERFORMED. BATCH REVIEW PERFORMED ON 20 MAY 2016. LOT 090233: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 MAY 2009. EXPIRATION DATE: 2014-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. NOT YET EXPLANTED.

    Description of Event or Problem · 1

    SUSPICION OF PREMATURE WEAR OF THE LEFT INLAY. THE PATIENT HAS PAIN AND PROBABLY A SECOND SURGERY WILL BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340653 VERSAFITCUP FLAT PE HC LINER Ø 36 / F FLAT PE LINER LZO MEDACTA INTERNATIONAL SA 090233

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other