BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3234206 · Received July 18, 2013

    Report

    Report Number
    0002249697-2013-02377
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 21, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SPECIFICS ARE AVAILABLE REGARDING THE PATIENTS OR THE CIRCUMSTANCES. NO FURTHER INFORMATION WAS RECEIVED. CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN SIMPLEX P CEMENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. PRODUCT NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A JBJ ARTICLE REPORTING AN UNCHANGED INFECTION RATE INVOLVING SIMPLEX P BONE CEMENT WITH ANTIBIOTIC VERSUS WITHOUT ANTIBIOTIC WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THIS EVENT DOES NOT RELATE TO A SPECIFIC PATIENT. THE STUDY CONCLUDED THE "THE USE OF ERYTHROMYCIN AND COLISTIN-LOADED BONE CEMENT IN TOTAL KNEE ARTHROPLASTY DID NOT LEAD TO A DECREASE IN THE RATE OF INFECTION WHEN SYSTEMIC PROPHYLACTIC ANTIBIOTICS WERE USED, A FINDING THAT SUGGESTS THAT THE USE OF ANTIBIOTIC-LOADED BONE CEMENT WOULD NOT BE INDICATED IN THE GENERAL POPULATION. FURTHER RESEARCH IS NEEDED TO ASSESS WHETHER ITS USE IS RECOMMENDED FOR PATIENTS WITH A HIGHER RISK OF INFECTION." ANTIBIOTIC BONE CEMENT IS PRE-BLENDED WITH ANTIBIOTICS TO MAINTAIN BONE CEMENT STRENGTH AND TO ENSURE UNIFORM ANTIBIOTIC COVERAGE. THE SELECTION OF BONE CEMENT WITH OR WITHOUT ANTIBIOTIC IS AT THE DISCRETION OF THE SURGEON. SELECTION OF BONE CEMENT WITH OR WITHOUT ANTIBIOTIC SHOULD CONSIDER IF THE CASE RELATES TO FACTORS SUCH AS PRIMARY OR REVISION SURGERY, AND PATIENT FACTORS SUCH AS HIGH RISK OF INFECTION.

    Description of Event or Problem · 1

    BONE JOINT SURG AM. 2013 MAY 1;95(9):769-74.- THE USE OF ERYTHROMYCIN AND COLISTIN-LOADED CEMENT IN TOTAL KNEE ARTHROPLASTY DOES NOT REDUCE THE INCIDENCE OF INFECTION - HINAREJOS P ET AL. - THIS PROSPECTIVE RANDOMIZED STUDY REPORTS THAT THE RATE OF DEEP INFECTION AND THE RATE OF SUPERFICIAL INFECTION WERE SIMILAR IN THE GROUP THAT USED ANTIBIOTIC LADEN CEMENT (N= 1465) AND THE GROUP THAT DID NOT USE ANTIBIOTIC LADEN CEMENT (N=1483) WITH CEMENTED KNEE ARTHROPLASTY. BOTH PATIENT POPULATIONS WERE COMPARABLE IN TERMS OF RISK FACTORS STUDIED. USE OF ANTIBIOTIC LADEN CEMENT DID NOT LEAD TO A DECREASE IN THE RATE OF INFECTION IN THIS STUDY.

    Description of Event or Problem · 1

    BONE JOINT SURG AM. 2013 MAY 1;95(9):769-74.- THE USE OF ERYTHROMYCIN AND COLISTIN-LOADED CEMENT IN TOTAL KNEE ARTHROPLASTY DOES NOT REDUCE THE INCIDENCE OF INFECTION - HINAREJOS P ET AL. - THIS PROSPECTIVE RANDOMIZED STUDY REPORTS THAT THE RATE OF DEEP INFECTION AND THE RATE OF SUPERFICIAL INFECTION WERE SIMILAR IN THE GROUP THAT USED ANTIBIOTIC LADEN CEMENT (N= 1465) AND THE GROUP THAT DID NOT USE ANTIBIOTIC LADEN CEMENT (N=1483) WITH CEMENTED KNEE ARTHROPLASTY. BOTH PATIENT POPULATIONS WERE COMPARABLE IN TERMS OF RISK FACTORS STUDIED. USE OF ANTIBIOTIC LADEN CEMENT DID NOT LEAD TO A DECREASE IN THE RATE OF INFECTION IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333032 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other