BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER TRILOGY HIP-LEFT

    MDR report key: 3172670 · Received June 12, 2013

    Report

    Report Number
    3172670
    Event Type
    Injury
    Date Received
    June 12, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 10, 2013
    Manufacturer
    ZIMMER
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS PT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2013, AT (B)(6). SHE WAS DISCHARGED TO A SKILLED NURSING FACILITY WHERE SHE DEVELOPED A FEVER, NAUSEA AND VOMITING. SHE WAS BROUGHT TO THE EMERGENCY DEPT AT (B)(6) HOSPITAL, ON (B)(6), AND DIAGNOSED WITH HIP INFECTION AND SEPTIC SHOCK. SHE WAS STABILIZED AND DISCHARGED BACK TO THE SKILLED FACILITY ON (B)(6), BUT THEN RETURNED TO (B)(6) ON (B)(6) WITH CHEST PAIN. SHE UNDERWENT DEBRIDEMENT AND IRRIGATION AND EXPLANT OF THE LEFT TOTAL HIP IN (B)(6). THE PT'S CONDITION CONTINUED TO DETERIORATE AND SHE EXPIRED ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265085 ZIMMER TRILOGY HIP-LEFT TOTAL HIP IMPLANT LPH ZIMMER
    265086 ZIMMER TILOGY LEFT-HIP TOTAL HIP IMPLANT LPH ZIMMER
    265087 ZIMMER TRILOGY HIP-LEFT TOTAL HIP IMPLANT LPH ZIMMER
    265088 ZIMMER TRILOGY HIP-LEFT TOTAL HIP IMPLANT LPH ZIMMER

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization