BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY SECUR-FIT PLUS #8/12

    MDR report key: 3234150 · Received July 18, 2013

    Report

    Report Number
    0002249697-2013-02376
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K982032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN AND SOFT TISSUE SWELLING INVOLVING A SECURFIT STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: THE PROVIDED RECORDS WERE REJECTED FOR REVIEW BY A CONSULTING CLINICIAN. READABLE X-RAYS, CLINICAL HISTORY, AND OPERATIVE REPORTS WOULD BE REQUIRED TO PROVIDE A MEANINGFUL DICTATION FOR THIS CASE. DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. COMPLAINT HISTORY REVIEW FOUND NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THE SUBJECT MANUFACTURING LOT. CONCLUSIONS: THE REPORTED EVENT INDICATED "SWELLING OF THE SOFT TISSUE [...] SURGEON NOTED WEAR. [...] PAIN WAS ORIGINATING FROM THE STEM." PAIN AND SWELLING ARE NOT DEVICE SPECIFIC FAILURE MODES, RATHER THEY ARE SYMPTOMS OF AN UNDERLYING ISSUE. FURTHER CLINICAL INFORMATION WOULD BE REQUIRE TO DETERMINE THE ETIOLOGY OF THE SYMPTOMS. THE SUBJECT FEMORAL STEM DOES NOT HAVE ANY INTERFACE WHICH WOULD ORDINARILY EXPERIENCE WEAR, WITHOUT FURTHER INFORMATION TO THE CONTRARY IT IS ASSUMED THIS COMMENT RELATES TO THE ASSOCIATED ACETABULAR LINER AND HEAD WHICH ARTICULATE WITH EACH OTHER. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED REVISION DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT COMPLAINED OF CHRONIC HIP PAIN, SURGERY WAS PERFORMED TO EXPLANT OLD IMPLANTS, AND AN MDM WAS IMPLANTED. PATIENT DID NOT PROVIDE SPECIFICS LAST SURGERY DATE. THE OLD IMPLANTS WERE UNABLE TO BE IDENTIFIED BY SPECIFIC LOT#. ON JULY 2, 2013, ADDITIONAL INFORMATION INDICATED THAT THE PATIENT HAD PAIN A FEW YEARS AFTER THE INITIAL SURGERY. AN X-RAY CONFIRMED SWELLING OF THE SOFT TISSUE AND UPON REVISION, THE SURGEON NOTED WEAR. IN ADDITION TO THE ACETABULAR COMPONENTS THAT WERE REVISED, THE STEM, 6054-0812S WAS ALSO REMOVED. IT WAS ALSO NOTED THAT THE PATIENT'S PAIN WAS ORIGINATING FROM THE STEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT COMPLAINED OF CHRONIC HIP PAIN, SURGERY WAS PERFORMED TO EXPLANT OLD IMPLANTS, AND AN MDM WAS IMPLANTED. PATIENT DID NOT PROVIDE SPECIFICS LAST SURGERY DATE. THE OLD IMPLANTS WERE UNABLE TO BE IDENTIFIED BY SPECIFIC LOT#. ON (B)(6) 2013, ADDITIONAL INFORMATION INDICATED THAT THE PATIENT HAD PAIN A FEW YEARS AFTER THE INITIAL SURGERY. AN X-RAY CONFIRMED SWELLING OF THE SOFT TISSUE AND UPON REVISION, THE SURGEON NOTED WEAR. IN ADDITION TO THE ACETABULAR COMPONENTS THAT WERE REVISED, THE STEM, 6054-0812S WAS ALSO REMOVED. IT WAS ALSO NOTED THAT THE PATIENT'S PAIN WAS ORIGINATING FROM THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334099 PRIMARY SECUR-FIT PLUS #8/12 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 93411203

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| R