BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLEXUR M

    MDR report key: 3180563 · Received June 20, 2013

    Report

    Report Number
    2246640-2013-00012
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 18, 2013
    Report Date
    May 21, 2013
    Manufacturer
    OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC)
    Product Code
    MQV
    PMA / PMN Number
    K073405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING TWO DEVICES (SAME PRODUCT) WERE ALSO REPORTEDLY IMPLANTED DURING THE PROCEDURE : CATALOG #: 6100-010, SERIAL #: (B)(4), CATALOG # 6100-020, SERIAL #: (B)(4). (B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE SUBJECT LOTS FOUND THAT THE DEVICES WERE MANUFACTURED PER PROCEDURE AND MET ALL REQUIRED SPECIFICATIONS. DETAILS OF THE REPORTED EVENT INDICATE THAT THE DEVICE PERFORMED WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING AN ACETABULAR CUP RECONSTRUCTION PROCEDURE, THE SURGEON USED RESORBABLE BONE VOID FILLER TO RESTORE THE ARCHITECTURE OF APPROXIMATELY 20% OF THE LATERAL ACETABULAR RIM. THE CUP IMPLANT WAS ANCHORED USING TWO AO SCREWS. APPROXIMATELY 4-6 WEEKS LATER, THE PATIENT PRESENTED WITH SUDDEN ONSET HIP PAIN AND DIFFICULTY AMBULATING ON THE AFFECTED SIDE. AN EMERGENCY REVISION PROCEDURE FOUND THAT THE CUP HAD DISPLACED AND WAS PARTIALLY FREE (SCREW LOOSENING). UPON PALPATION OF THE RESORBABLE BONE VOID FILLER, THE REVISING SURGEON NOTED THAT THE PRODUCT HAD SOFTENED AND ¿CRUMBLED.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279549 PLEXUR M FILLER, BONE VOID, CALCIUM COMPOUND MQV OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC) 6100-010

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Hospitalization| R