BEUDAMED
    FDA Adverse Event Summary report: N

    FOUNDATION HIP

    MDR report key: 3010572 · Received March 19, 2013

    Report

    Report Number
    1644408-2013-00156
    Date Received
    March 19, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWA
    PMA / PMN Number
    K040354
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS OSTEOLYSIS OF THE ACETABULUM AND A LOOSE CUP DUE TO A CYST AFTER 2.3 YEARS OF PATIENT USE. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. THERE WAS ONE NON-CONFORMING MATERIAL REPORT FOR THE SCREW PART NUMBER (B)(4); ONE FOR BURRS AND SIX PARTS WERE REWORKED FOR WAVES AT THE EDGE OF THE SCREWS, THE PARTS WERE ACCEPTED. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE EIGHTH COMPLAINT FOR THIS PART NUMBER: ONE DAMAGED PART, ONE DUE TO EXCESSIVE WEAR, TWO DUE TO PAIN, TWO DUE TO DISSOCIATION, ONE DUE TO OSTEOLYSIS, AND ONE FOR A METAL REACTION. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE OSTEOLYSIS AND CYST WAS NOT DETERMINED WITH CONFIDENCE. SEVERAL FACTORS CAN CONTRIBUTE TO OSTEOLYSIS INCLUDING: AGE, DISEASE, MEDICAL CONTRAINDICATION, DISTAL LOADING OF THE IMPLANT, OR INSUFFICIENT PROXIMAL BONE BEFORE THE PRIMARY SURGERY. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO OSTEOLYSIS OF THE ACETABULUM. THE CUP BECAME LOOSE AND THE DOCTOR REMOVED THE ACETABULAR COMPONENTS DUE TO A CYST BEHIND THE CUP. HE LEFT THE SIZE 15 RIGHT STEM IN PLACE AND REVISED WITH A NEW DJO SURGICAL HEAD; THE SURGEON REPLACED ALL OTHER EXPLANTED PARTS WITH ANOTHER MANUFACTURER'S PARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113309 FOUNDATION HIP METAL-ON-METAL LINER - NEUTRAL, MP8 KWA ENCORE MEDICAL, L.P. 54043018

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention 411-00-035, LOT 54037128| 010-55-030, LOT 54014678| 010-55-030, LOT A1000002| 430-01-052, LOT 284C1010| 497-34-000, LOT A1000012