BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION ADM X3 INS 28/54

    MDR report key: 3309742 · Received August 27, 2013

    Report

    Report Number
    0002249697-2013-02840
    Event Type
    Injury
    Date Received
    August 27, 2013
    Date of Event
    August 5, 2013
    Report Date
    August 5, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K093644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT # 626-00-48G, LOT # 41171201, DESCRIPTION: MODULAR DUAL MOBILITY INSERT; CAT # 18-2805, LOT # 42069801, DESCRIPTION: DELTA C-TAPER HEAD 28MM +5; CAT # 17-0000E, LOT # MLH8L1, DESCRIPTION: TI SLEEVE FOR ALUMINA HEAD. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING AN ADM LINER WAS REPORTED. THE EVENT WAS CONFIRMED. A REVIEW OF THE PROVIDED INFORMATION BY A CLINICAL CONSULTANT INDICATED THAT: SEQUENCE OF EVENTS AND PROCEDURES WERE ESTABLISHED WITH THE ROOT PROBLEM BEING THE OCCURRENCE OF AN EARLY POSTOPERATIVE HEMATOMA AFTER THE REVISION PROCEDURE IN (B)(6) 2013 THAT SHOULD BE CONSIDERED A MAJOR RISK FACTOR FOR THE LATER DEVELOPMENT OF INFECTION IN THE ARTHROPLASTY. DEVICE HISTORY REVIEW: THERE WERE NO REPORTED DISCREPANCIES FOR THE REPORTED LOT OR STERILE LOT. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT OR STERILE LOT REFERENCED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION SUCH AS ANALYSIS OF THE EXPLANTED DEVICES AS WELL AS X-RAYS AND MEDICAL RECORDS IS NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING THE ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD BLEEDING AND CONTAMINATION AFTER SURGERY AND INFECTION. SURGEON DID A WASHOUT AND DEBRIDEMENT. TOOK OUT THE LINER, BALL, INSERT AND SLEEVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD BLEEDING AND CONTAMINATION AFTER SURGERY AND INFECTION. SURGEON DID A WASHOUT AND DEBRIDEMENT. TOOK OUT THE LINER, BALL, INSERT AND SLEEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419072 RESTORATION ADM X3 INS 28/54 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 42478401

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention