BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE PIP SZ. 2

    MDR report key: 7566856 · Received June 4, 2018

    Report

    Report Number
    1651501-2018-00028
    Event Type
    Injury
    Date Received
    June 4, 2018
    Report Date
    May 23, 2018
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    KYJ
    PMA / PMN Number
    K082231
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTAL HYGIENIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. REVIEW OF MANUFACTURING RECORDS SHOWED NO EVIDENCE OF A NONCONFORMANCE THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION RECEIVED TO DATE, THE ROOT CAUSE IS UNDETERMINED. THE EVENT MAY BE DUE TO TRAUMA OR AN IMPROPERLY SEATED IMPLANT LEADING TO ADDITIONAL STRESS ON THE HINGE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPIP-520-2-WW SILICONE PIP IMPLANT SHOWED SIGNS OF TEAR AND BREAKAGE. ON (B)(6) 2016, AN ATHRODESIS OF THE PIPJ WAS PERFORMED WITH A SPIP-520-2-WW SILICONE PIP IMPLANT. HOWEVER, 2 YEARS POST IMPLANTATION, THE IMPLANT SHOWED SIGNS OF TEAR AND BREAKAGE WITH SIGNS OF LATERAL SHIFT. NO SPECIFIC TRAUMA OR CONTRIBUTING EVENTS PRIOR TO THE DISCOVERY OF THE ISSUE. SUBSEQUENTLY, THE IMPLANTED PRODUCT WAS EXPLANTED ON (B)(6) 2018 AND WAS REPLACED WITH ANOTHER OF THE SAME SIZE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DOING WELL AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409630 SILICONE PIP SZ. 2 SILICONE PIP KYJ ASCENSION ORTHOPEDICS 161334T

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention