BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 4090357 · Received September 15, 2014

    Report

    Report Number
    0002249697-2014-03466
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN SERIES II LINER. ADDITIONALLY, AN UNKNOWN SECUREFIT CUP AND SCREWS WERE REPORTED. BASED ON THE MINIMAL INFORMATION RECEIVED, IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) CENTIMETERS IN HEIGHT. AN EVENT REGARDING INFECTION INVOLVING A SERIES 2 LINER WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR IDENTIFICATION OR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED MEDICAL RECORDS AND/OR X-RAYS BY A CLINICAL CONSULTANT CONCLUDED: ¿[¿]THERE IS NO EVIDENCE THAT THIS INFECTED LEFT TOTAL HIP ARTHROPLASTY APPROXIMATELY TWENTY YEARS POST-IMPLANTATION REQUIRING REVISION IN A HIGH RISK PATIENT (HEMOPHILIA AND PREVIOUS INFECTIONS) WAS RELATED TO THE PROSTHETIC COMPONENTS INITIALLY IMPLANTED IN THIS CASE. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT PER CLINICAL CONSULTANT¿S MEDICAL REVIEW THERE IS NO EVIDENCE THAT THIS INFECTED LEFT TOTAL HIP ARTHROPLASTY APPROXIMATELY TWENTY YEARS POST-IMPLANTATION REQUIRING REVISION IN A HIGH RISK PATIENT WAS RELATED TO THE PROSTHETIC COMPONENTS INITIALLY IMPLANTED IN THIS CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAS PAIN OF THE LEFT HIP WHICH WAS DONE AROUND 1995. PATIENT WAS FOUND TO BE INFECTED INTRAOP. THE SECURE FIT CUP, SERIES 2 LINER AND 2 SCREWS WERE REMOVED. SURGEON IMPLANTED A TEMPORARY CEMENT SPACER AND WILL RETURN ONCE TO INFECTION HAS CLEARED. HOSPITAL WILL BE RETAINING THE EXPLANTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAS PAIN OF THE LEFT HIP WHICH WAS DONE AROUND 1995. PATIENT WAS FOUND TO BE INFECTED INTRAOP. THE SECURE FIT CUP, SERIES 2 LINER AND 2 SCREWS WERE REMOVED. SURGEON IMPLANTED A TEMPORARY CEMENT SPACER AND WILL RETURN ONCE TO INFECTION HAS CLEARED. HOSPITAL WILL BE RETAINING THE EXPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568184 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention