BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SULZERMEDICA

    MDR report key: 644181 · Received October 27, 2005

    Report

    Report Number
    644181
    Event Type
    Injury
    Date Received
    October 27, 2005
    Date of Event
    August 2, 2005
    Report Date
    September 23, 2005
    Manufacturer
    ZIMMER
    Product Code
    HSH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS PT HAS A HEMIARTHROPLASTY LEFT KNEE IN 2004. HE HAS HAD CONTINUED COMPLAINTS OF PAIN FROM NEUROMA AND SCIATIC NERVE PAIN AND POSTERIOR KNEE PAIN. HE STATES HE HAS MORE PAIN THAN BEFORE SURGERY. HE WAS ADMITTED FOR A REVISION LEFT KNEE ARTHROPLASTY. DURING THE PROCEDURE ALL COMPONENTS WERE REMOVED AND REPLACED. IN ACCORDANCE WITH HOSP POLICY, THE REMOVED COMPONENTS ARE NOT AVAILABLE FOR RELEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SULZERMEDICA NONPOROUS UNI-COMPARTMENTAL TIBIAL BASEPLATE HSH ZIMMER * 1502818
    2 SULZERMEDICA NONPOROUS UNI-COMPARTMENTAL TIBIAL BASEPLATE HSH ZIMMER * 1502818
    3 CENTERPULSE CONGRUENT UNI-COMPARTMENTAL TIBIAL INSERT HSH ZIMMER * 1563489
    4 CENTERPULSE UNI-COMPARTMENTAL NONPOROUS FEMORAL HSA ZIMMER * 1564315

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R