BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT PSL HA CLUSTER 54MM

    MDR report key: 4140308 · Received October 3, 2014

    Report

    Report Number
    0002249697-2014-03751
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 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 DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING DISLOCATION INVOLVING A TRIDENT SHELL WAS REPORTED. CONCLUSION: CLINICIAN REVIEW OF THE PROVIDED RECORDS INDICATED THE ROOT CAUSE OF THE DISLOCATION TO BE MALPOSITION OF THE ASSOCIATED FEMORAL STEM. BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED FOR DISLOCATION. DR. (B)(6) DID HIS PRIMARY HIP REPLACEMENT. DR. (B)(6) DID HIS REVISION SURGERY. DR. (B)(6) NOTED METAL DEBRIS AFTER REMOVING THE HEAD. HE THEN CONVERTED TO A MDM LINER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED FOR DISLOCATION. DR. (B)(6) DID HIS PRIMARY HIP REPLACEMENT. DR. (B)(6) DID HIS REVISION SURGERY. DR. (B)(6) NOTED METAL DEBRIS AFTER REMOVING THE HEAD. HE THEN CONVERTED TO A MDM LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618464 TRIDENT PSL HA CLUSTER 54MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH MKP9Y3

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention