BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDERCUP

    MDR report key: 8211670 · Received January 3, 2019

    Report

    Report Number
    0009610576-2019-00001
    Event Type
    Injury
    Date Received
    January 3, 2019
    Report Date
    January 3, 2019
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    PBI
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET IN THE UNITED STATES; HOWEVER, WE ARE FILING THIS REPORT AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K030055. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    "AS PART OF THE POST MARKET SURVEILLANCE (PMS) OF THE SPIDERCUP CUP, THE PMS TEAM HAS REVIEWED THE SURVEY COMPLETED BY DR. (B)(6) OF THE (B)(6) HOSPITAL ((B)(6)). DURING THE REVIEW OF THE SURVEY SEVERAL EVENTS WERE DETECTED ABOUT THE INCIDENTS THAT ARE MENTIONED: POST-OPERATIVE COMPLICATIONS (DEEP INFECTION> 3 MONTHS ""1 CASE FOR EVERY 100 PROSTHESES""; LUXATION ""DUE TO ERRONEOUS ORIENTATION OF THE CUP"") IMPLANT REVISION, CAUSE BY RECURRENT DISLOCATION (""REVISION DUE TO POLYETHYLENE WEAR AND DISLOCATION AT 10 YEARS, TOTAL 3 CASES"")"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4351 SPIDERCUP PROSTHESIS, HIP PBI BIOMET SPAIN, S.L. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1