BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL

    MDR report key: 3923034 · Received July 9, 2014

    Report

    Report Number
    0002249697-2014-02578
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    December 29, 2008
    Report Date
    June 11, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K013676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME DUE TO ONGOING LITIGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING STEM SUBSIDENCE INVOLVING A TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL WAS REPORTED. CONCLUSION: A REVIEW OF THE MEDICAL RECORDS INDICATED THE SHELL WAS WELL FIXED AND APPEARED TO HAVE NO PROBLEMS. THIS COMPONENT WAS NOT REVISED. BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING SHELL LOOSENING INVOLVING A TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR EVALUATION. NO MEDICAL RECORDS OR X-RAYS WERE MADE AVAILABLE FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW. THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION.

    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 ON (B)(6) 2008. IT IS ALLEGED THAT PATIENT BEGAN TO EXPERIENCE INCREASED LEVELS OF PAIN AND "HAD ASEPTIC LOOSENING ON HIS LEFT HIP IMPLANT." IT IS FURTHER ALLEGED THAT THE "BLOOD TESTING REVEALED TOXIC LEVELS OF COBALT IN HIS BLOODSTREAM." THE PATIENT WAS REVISED ON (B)(6) 2013 AND THAT THE "LEFT HIP IMPLANT HAD NO FIXATION AT ALL WHICH ALLOWED THE LEFT HIP IMPLANT TO BE SPUN OUT AND REMOVED QUITE EASY BY THE SURGEON."

    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 ON (B)(6) 2008. IT IS ALLEGED THAT PATIENT BEGAN TO EXPERIENCE INCREASED LEVELS OF PAIN AND "HAD ASEPTIC LOOSENING ON HIS LEFT HIP IMPLANT." IT IS FURTHER ALLEGED THAT THE "BLOOD TESTING REVEALED TOXIC LEVELS OF COBALT IN HIS BLOODSTREAM." THE PATIENT WAS REVISED ON (B)(6) 2013 AND THAT THE "LEFT HIP IMPLANT HAD NO FIXATION AT ALL WHICH ALLOWED THE LEFT HIP IMPLANT TO BE SPUN OUT AND REMOVED QUITE EASY BY THE SURGEON."

    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 ON (B)(6) 2008. IT IS ALLEGED THAT PATIENT BEGAN TO EXPERIENCE INCREASED LEVELS OF PAIN AND "HAD ASEPTIC LOOSENING ON HIS LEFT HIP IMPLANT." IT IS FURTHER ALLEGED THAT THE "BLOOD TESTING REVEALED TOXIC LEVELS OF COBALT IN HIS BLOODSTREAM." THE PATIENT WAS REVISED ON (B)(6) 2013 AND THAT THE "LEFT HIP IMPLANT HAD NO FIXATION AT ALL WHICH ALLOWED THE LEFT HIP IMPLANT TO BE SPUN OUT AND REMOVED QUITE EASY BY THE SURGEON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399323 TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 28294201

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R