BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION HIP

    MDR report key: 2885347 · Received December 19, 2012

    Report

    Report Number
    1644408-2012-00666
    Event Type
    Other
    Date Received
    December 19, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 7, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWA
    PMA / PMN Number
    K003250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2012 AN AGENT REPORTED THAT A REVISION SURGERY WAS PERFORMED BECAUSE A PATIENT EXPERIENCED A METAL REACTION. BASED ON THE X-RAY THE REP SUGGESTED THE PATIENT MAY HAVE DJO SURGICAL'S FMP ACETABULAR CUP WITH METAL-ON-METAL LINER, SIZE 28MM. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2001, MEANING THE COMPONENTS HAD BEEN IN-VIVO APPROXIMATELY 11 YEARS 6 MONTHS. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. 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. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THERE HAVE BEEN NINE COMPLAINTS AGAINST THE FEMORAL HEAD, NONE OF THE COMPLAINTS INVOLVE METAL REACTION. THERE HAVE BEEN TEN COMPLAINTS AGAINST THE METAL-METAL LINER; THIS IS THE SECOND COMPLAINT FOR A METAL REACTION. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE REVISION SURGERY IS LISTED AS A METAL REACTION. BECAUSE NO COMPONENTS WERE RETURNED TO DJO SURGICAL FOR INSPECTION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. METAL SENSITIVITY IS A RECOGNIZED ADVERSE AFFECT OF THE METAL-ON-METAL LINER. THE DJO SURGICAL HIP SYSTEM IFU STATES: METAL SENSITIVITY REACTIONS IN PATIENTS FOLLOWING JOINT REPLACEMENT HAVE BEEN RARELY REPORTED. FACTORS THAT CAN CONTRIBUTE TO METAL-METAL REACTION OR PAIN INCLUDE: HYPERSENSITIVITY TO METAL, INCREASED METAL WEAR DUE TO HIGH PATIENT ACTIVITY LEVEL, AND MALPOSITIONED COMPONENTS. THERE IS NO INDICATION OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT HAD A METAL REACTION. BASED ON X-RAYS, THE AGENT SUGGESTED THE PATIENT MAY HAVE (B)(4)'S 28MM FMP ACETABULAR CUP WITH METAL ON METAL LINER. THE STEM IS A PLUS (B)(4) WITH A SIZE 28MM HEAD THAT HAS A 12/14 TAPER. THE SURGEON REPLACED THE LINER AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION HIP METAL-ON-METAL LINER-NEUTRAL, MP 9 KWA ENCORE MEDICAL, L.P. 595581

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention 497-28-350, LOT 696371