BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUUM TRABECULAR METAL SHELL

    MDR report key: 2875135 · Received December 12, 2012

    Report

    Report Number
    1822565-2012-02531
    Event Type
    Injury
    Date Received
    December 12, 2012
    Report Date
    November 14, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT HAD PAIN IN THE LATERAL ASPECT OF HIS HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINUUM TRABECULAR METAL SHELL LZO ZIMMER, INC. 62146537

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LOT #62053411| BIOLOX DELTA HEAD: CATALOG #00877503601,| ALLOFIT IT LONGEVITY LINER: LOT #62061147,| MFG BY ZIMMER (B)(4)| BONE SCREW: CATALOG #00625006535, LOT #62119849,| (B)(4)| LOT #2645292, MFG BY ZIMMER| MFG BY ZIMMER (B)(4)| ZIMMER M/L FEMORAL STEM: CATALOG #00771100940,| MFG BY ZIMMER (B)(4)| CONTINUUM, TRIOLOGY IT: CATALOG #00875101136| BONE SCREW: CATALOG #00625006525, LOT # 62143447,