BEUDAMED
    FDA Adverse Event Summary report: N

    X-ALT HIP

    MDR report key: 3063857 · Received April 17, 2013

    Report

    Report Number
    1644408-2013-00220
    Date Received
    April 17, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K072154
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THE COMPLAINT WAS DURING THE PRIMARY SURGERY THE LINERS WOULD NOT FIT/LOCK INTO THE SHELL. THERE WAS A 30 MINUTE DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS RETURNED TO DJO SURGICAL AND WAS VISUALLY EXAMINED. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. A VISUAL EXAMINATION OF THE RETURNED PRODUCTS REVEALED A SCREW HEAD INDENTATION ON THE BACK SIDE OR OUTER DIAMETER OF EACH LINER. CRITICAL DIMENSIONS (INCLUDING SNAP ENGAGEMENT FEATURES, OVERALL HEIGHT, SCALLOP DIAMETER) MEASURED WITHIN SPECIFICATION. THE INSPECTION SUGGESTS THE LINER WAS WITHIN CRITICAL SPECIFICATIONS WHEN USED IN ORIGINAL SURGERY. THE PROBABLE ROOT CAUSE OF THIS COMPLAINT IS A PARTIALLY INSERTED BONE SCREW INTO THE FMP SHELL BONE SCREW HOLES WHICH STOPPED THE LINER FROM BEING ABLE TO LOCK INTO THE SHELL. OTHER FACTORS THAT CAN CONTRIBUTE TO THE POLY LINER NOT ENGAGING THE SHELL INCLUDE INADEQUATE IMPACTION FORCE, IMPROPER ALIGNMENT, AND DEBRIS IN THE ACETABULAR SHELL. THERE WAS NO INFORMATION REPORTED THAT SHOWED A MATERIAL OR MANUFACTURING PROBLEM WITH THE PRODUCT.

    Description of Event or Problem · 1

    PRIMARY SURGERY - THE MP8 LINERS, WOULD NOT FIT INTO THE MP8 SIZE 54 SHELL; FOUR SUBSEQUENT LINERS WERE WASTED IN THE PROCESS. THIS EVENT RESULTED IN A 30 MINUTE DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165070 X-ALT HIP LINER / 10 DEGREE HOODED / NEUTRAL, MP8 LPH ENCORE MEDICAL, L.P. 730F1042

    Patients

    Seq Age Sex Outcome Treatment
    1 Other (B)(4), LOT 730F1042| (B)(4), LOT 730F1048| (B)(4), LOT 730F1042| (B)(4), LOT 285C1051