BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT PSL HA CLUSTER 52MM

    MDR report key: 3924314 · Received July 9, 2014

    Report

    Report Number
    0002249697-2014-02588
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K983382
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE SALES REP. IS WORKING ON OBTAINING MEDICAL RECORDS AND X-RAYS FOR THE EVALUATION OF THE REPORTED EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING SHELL MALPOSITION INVOLVING A TRIDENT PSL HA CLUSTER 52MM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW CONFIRMED NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE OF A LACK OF INFORMATION. FURTHER INFORMATION SUCH AS THE REVISION OPERATIVE REPORT, OPERATIVE FINDINGS, AND PATHOLOGY REPORTS ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING THE ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED FOR HIP PAIN. THE SURGEON REMOVED THE CERAMIC HEAD AND LINER. AT THE TIME OF REMOVAL, HE NOTED DISCOLORED SOFT TISSUE AT THE BASE OF THE NECK. HE REMOVED THE ACETABULAR SHELL AND LINER. HE THEN PUT IN A NEW TRIDENT CUP WITH A MDM LINER. ON (B)(6) 2014: THE SALES REP. CONFIRMED THAT THE SHELL WAS MALPOSITIONED AND WAS REVISED BECAUSE THE PATIENT WAS EXPERIENCING PAIN. ALSO, THERE WAS SOFT TISSUE DISCOLORATION FOUND NEAR THE BASE OF THE NECK. THE STEM WAS NOT REVISED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED FOR HIP PAIN. THE SURGEON REMOVED THE CERAMIC HEAD AND LINER. AT THE TIME OF REMOVAL, HE NOTED DISCOLORED SOFT TISSUE AT THE BASE OF THE NECK. HE REMOVED THE ACETABULAR SHELL AND LINER. HE THEN PUT IN A NEW TRIDENT CUP WITH A MDM LINER. ON 06/30/2014: THE SALES REP. CONFIRMED THAT THE SHELL WAS MALPOSITIONED AND WAS REVISED BECAUSE THE PATIENT WAS EXPERIENCING PAIN. ALSO, THERE WAS SOFT TISSUE DISCOLORATION FOUND NEAR THE BASE OF THE NECK. THE STEM WAS NOT REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399958 TRIDENT PSL HA CLUSTER 52MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 69EMJE

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R