BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR HIP

    MDR report key: 4182462 · Received October 17, 2014

    Report

    Report Number
    1644408-2014-00650
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K974294
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS FOR STEM SUBSIDENCE AFTER 3 MONTHS 17 DAYS IN VIVO. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED THERE ARE (B)(4) COMPLAINTS AGAINST THE INCIDENT LINEAR STEM. OF THESE (B)(4) COMPLAINTS, (B)(4) COMPLAINTS WERE FOR SIMILAR FAILURE AND REST (B)(4) ARE FOR STEM MISMATCH ISSUE. A DEFINITIVE ROOT CAUSE FOR THE STEM SUBSIDENCE WAS NOT REPORTED AND CANNOT BE DETERMINED WITH CONFIDENCE. SEVERAL FACTORS NOT RELATED TO THE IMPLANT THAT CAN PLAY A ROLE IN SUBSIDENCE SUCH AS POOR BONE CONDITION, FRACTURE OF THE PROXIMAL FEMUR, CHOICE OF AN INAPPROPRIATE SIZE IMPLANT FOR PATIENT ANATOMY, PATIENT WEIGHT AND PATIENT ACTIVITIES OR TRAUMA. 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 THE STEM SUBSIDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660316 LINEAR HIP LINEAR STANDARD OFFSET STEM 7 LPH ENCORE MEDICAL, L.P. 057C1133

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention 932-36-254,LOT 730F1086| 400-03-361,LOT 864B1080