BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT PSL HA CLUSTER 54MM

    MDR report key: 3875331 · Received June 16, 2014

    Report

    Report Number
    0002249697-2014-02311
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    October 3, 2005
    Report Date
    May 27, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K983382
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPARTMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME DUE TO THE ONGOING LITIGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING SHELL LOOSENING INVOLVING A TRIDENT PSL HA CLUSTER 54MM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. -MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT RECORDS WERE PROVIDED FOR A CLINICAL DICTATION REGARDING THIS EVENT. -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 ADDITIONAL MEDICAL RECORDS AND X-RAYS DESCRIBING THE REPORTED EVENT AS WELL AS THE REPORTED DEVICE ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING THE ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ATTORNEY FOR THE PATIENT AS A RESULT OF A LAWSUIT THAT ALLEGEDLY THE PATIENT UNDERWENT LEFT HIP SURGERY USING TRIDENT ACETABULAR HIP SYSTEM ON (B)(6) 2005. IT IS ALLEGED THE PATIENT BEGAN TO EXPERIENCE EXTREME PAIN AND LOOSENING OF DEVICE. THE PATIENT WAS REVISED ON (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ATTORNEY FOR THE PATIENT AS A RESULT OF A LAWSUIT THAT ALLEGEDLY THE PATIENT UNDERWENT LEFT HIP SURGERY USING TRIDENT ACETABULAR HIP SYSTEM ON (B)(6), 2005. IT IS ALLEGED THE PATIENT BEGAN TO EXPERIENCE EXTREME PAIN AND LOOSENING OF DEVICE. THE PATIENT WAS REVISED ON (B)(6), 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352517 TRIDENT PSL HA CLUSTER 54MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 24467101

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention