BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR HIP

    MDR report key: 4143822 · Received October 6, 2014

    Report

    Report Number
    1644408-2014-00625
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWY
    PMA / PMN Number
    K953510
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS A RESULT OF PATIENT CHRONIC DISLOCATIONS AFTER APPROXIMATELY 15 YEARS OF PATIENT USE. A 430-01-054 SHELL WAS REPORTED AS EXPLANTED AND THE LOT NUMBER WAS NOT REPORTED. THIS IS THE SECOND REVISION AND EXPLANTED PART NUMBERS 496-28-052 AND 497-28-000 WERE IMPLANTED AT THE FIRST REVISION ON (B)(6) 2004 WHILE THE 430-01-054 SHELL WAS IMPLANTED SOMETIME IN 1999. IT WAS REPORTED THE PATIENT WAS PART OF A CLINICAL STUDY AND A REQUEST WAS MADE TO CLINICAL AFFAIRS TO PROVIDE THE LOT NUMBER. CLINICAL AFFAIRS HAS REPORTED THE LOT INFORMATION FOR THE 1999 SURGERY IS NOT AVAILABLE. MULTIPLE SEARCHES OF THE DATABASE PRODUCED NO INFORMATION CONCERNING THE 1999 SURGERY. THE HEALTHCARE PROFESSIONAL INDICATED A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. 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 THIS IS THE FIRST COMPLAINT AGAINST LOT NUMBER 964121. A TOTAL OF TWO COMPLAINTS HAVE BEEN SUBMITTED AGAINST THIS PART NUMBER. THIS IS THE FIRST COMPLAINT SUBMITTED FOR A DISLOCATION. THE SECOND COMPLAINT IS THE RESULT OF INSTABILITY. NO INFORMATION WAS PROVIDED THAT EXPLAINS THE NATURE OR ROOT CAUSE OF THE DISLOCATIONS. FACTORS UN-RELATED TO THE IMPLANTS THAT MAY CONTRIBUTE TO A PATIENT DISLOCATION ARE: DEGENERATIVE BONE, IMPROPER SURGICAL TECHNIQUE OR INCORRECT IMPLANT SELECTION. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    SECOND REVISION SURGERY - THE PATIENT HAD A BILATERAL HIP REPLACEMENT IN 1999 WITH A FOOD AND DRUG ADMINISTRATION STUDY USING ENCORE CERAMIC HIPS. THE RIGHT HAD A PAINFUL SQUEAL NOTED WITH AMBULATION AND WAS REVISED ON (B)(6) 2004. THE PATIENT RETURNED WITH CHRONIC DISLOCATION. THE SURGEON REMOVED THE OLD 54 MM ACETABULAR CUP, THE 52/54MM ACETABULAR LINER AND THE 28 NEUTRAL COCR HEAD. HE REPLACED THE CUP AND LINER WITH ZIMMER COMPONENTS AND REPLACED THE FEMORAL HEAD WITH A 36 MM COCR HEAD AND A -3.5 OFFSET SLEEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623850 BIPOLAR HIP LINER, PE AL-AL 28X52 / 54 KWY ENCORE MEDICAL, L.P. 964121

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| R (B)(4), LOT 949731| (B)(4), LOT 964121