BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM

    MDR report key: 2913006 · Received January 14, 2013

    Report

    Report Number
    0002249697-2013-00032
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K081171
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. (B)(4): NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. THE EVENT WAS NOT CONFIRMED. THE INVESTIGATION CONCLUDED THAT THE ROOT CAUSE OF THIS EVENT WAS DETERMINED TO BE AN OFF LABEL USE. BONE STOCK COMPROMISED BY DISEASE, INFECTION OR PRIOR IMPLANTATION WHICH CANNOT PROVIDE ADEQUATE SUPPORT AND/OR FIXATION TO THE PROSTHESIS IS A KNOWN CONTRAINDICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON WAS DOING A RIGHT TOTAL HIP AND SURGEON IMPLANTED A CUP AND WHEN SURGEON IMPACTED THE LINER, THE CUP POSITION CHANGED DUE TO POOR PATIENT BONE QUALITY. SURGEON USED A NEW LINER AND COMPLETED THE CASE WITHOUT ANY DELAY IN THE CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON WAS DOING A RIGHT TOTAL HIP AND SURGEON IMPLANTED A CUP AND WHEN SURGEON IMPACTED THE LINER, THE CUP POSITION CHANGED DUE TO POOR PATIENT BONE QUALITY. SURGEON USED A NEW LINER AND COMPLETED THE CASE WITHOUT ANY DELAY IN THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20740 PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MLM3EM

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention