BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUUM TM SHELL WITH CLUSTER HOLES

    MDR report key: 5025481 · Received August 24, 2015

    Report

    Report Number
    1822565-2015-01567
    Event Type
    Injury
    Date Received
    August 24, 2015
    Date of Event
    July 13, 2015
    Report Date
    July 27, 2015
    Manufacturer
    ZIMMER INC
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER DEVICES USED: CATALOG #00771101220, M/L TAPER FEMORAL PRESS-FIT STEM, LOT #61792365 THE FOLLOWING PRODUCTS WERE MANUFACTURED BY ZIMMER B.V., (B)(4): CATALOG #00625006530, TRILOGY BONE SCREW, LOT #62021167; CATALOG #00625006520, TRILOGY BONE SCREW, LOT #62044212 THESE DEVICES ARE USED FOR TREATMENT. REVIEW OF THE PRIMARY SURGERY NOTES CONFIRMS THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY DUE TO OSTEOARTHRITIS. THE HIP WAS ARTICULATED AND PLACED THROUGH A FULL RANGE OF MOTION AND THE LEG LENGTHS WERE CHECKED AND WERE EQUAL. REVIEW OF THE REVISION SURGERY NOTES CONFIRMS THAT THE PATIENT UNDERWENT REVISION RIGHT TOTAL HIP ARTHROPLASTY DUE TO ACUTE HEMATOGENOUS INFECTION. IT WAS NOTED IN THE REVISION SURGERY NOTES THAT UPON OPENING THE FASCIA A RUSH OF PURULENT FLUID WERE OBTAINED. THE LINER AND THE FEMORAL HEAD WERE EXPLANTED. IT WAS ALSO NOTED THAT THERE WAS ACUTE INFECTION WITH A SIGNIFICANT AMOUNT OF FLUID IN THE HIP CAPSULE. REVIEW OF THE COMPATIBILITY OF THE RETURNED DEVICES CONFIRMED THAT THESE ARE AN APPROVED COMPATIBLE COMBINATION. SINGLE-USE, STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICE CAUSED OR CONTRIBUTED TO ANY PATIENT INFECTION. A DEFINITE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG #00877503601, BIOLOX DELTA HEAD, LOT #2632484, MANUFACTURED BY ZIMMER GMBH, (B)(4), EXPLANTED ON (B)(6) 2015. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT WAS REVISED AND AN I&D PERFORMED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558308 CONTINUUM TM SHELL WITH CLUSTER HOLES LZO LZO ZIMMER INC 62035286

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention