BEUDAMED
    FDA Adverse Event Other Summary report: N

    FMP HIP

    MDR report key: 3224398 · Received July 10, 2013

    Report

    Report Number
    1644408-2013-00362
    Event Type
    Other
    Date Received
    July 10, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 4, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K974095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS A POLY SWAP DUE TO INSTABILITY. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT ACTIVITY LEVEL, TRAUMA, DISEASE, OR MEDICAL CONTRAINDICATIONS THAT COULD HAVE CONTRIBUTED TO INSTABILITY. THERE WAS A DELAY OF ONE HOUR 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 SHOWS THIS IS THE FIFTH COMPLAINT FOR THIS PRODUCT. THE ROOT CAUSE OF THIS FAILURE INVESTIGATION IS LIMITED IN SCOPE SINCE THE EXPLANTED PRODUCTS FROM THE SURGERY IS NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. SEVERAL POTENTIAL FACTORS NOT RELATED TO THE IMPLANT CAN PLAY A ROLE IN INSTABILITY SUCH AS: PATIENT ACTIVITY, LOOSE JOINT FROM INADEQUATE SOFT TISSUE, AND IMPLANT SELECTION. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE SURGEON DID A POLY SWAP DUE TO INSTABILITY. THE SURGEON HAD PROBLEMS WITH INSERTING THE NEW 935-28-248, ACETABULAR 10 DEG HOODED, HXL/FMP, +5 OFFSET 28 ID, MP5 LINERS INTO THE ORIGINAL SHELL, 430-03-048. NO DEBRIS WAS FOUND, AND THE LINERS WOULD NOT SNAP INTO THE LIP OF THE OLD SHELL. THE SURGEON DECIDED TO REPLACE IT WITH A COMPETITOR'S SHELL AND LINER AND REPLACED THE HEAD WITH A DJO FEMORAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316196 FMP HIP FLARED RIM SHELL W/ SCREWHOLES LPH ENCORE MEDICAL, L.P. 478821

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention 432-28-005: LOT 526581| 400-01-284: LOT 468421