BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-TAPER INTER.NK HEAD

    MDR report key: 2926288 · Received January 23, 2013

    Report

    Report Number
    0002249697-2013-00184
    Event Type
    Injury
    Date Received
    January 23, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 10, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K910988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    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 DEVICE WAS NOT RETURNED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE LIMITED INFORMATION AVAILABLE AT THE TIME OF EVALUATION. IT IS LIKELY THAT THE DISLOCATION MAY HAVE OCCURRED DUE TO THE FACT THAT ANOTHER MANUFACTURERS¿ DEVICE WAS USED IN CONJUNCTION WITH A STRYKER DEVICE. BASED ON THE RESULTS OF THE EVALUATION, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DR (B)(6) USED A ZIMMER REVISION CUP FOR THIS PATIENT ON (B)(6) 2012. HE USED A STRYKER 32 MM HEAD AT THAT TIME. THE PATIENT THEN DISLOCATED AFTER THE FIRST REVISION. HE THEN USED A CONSTRAINED LINER FROM ZIMMER AND A 28 MM HEAD FROM STRYKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DR (B)(6) USED A ZIMMER REVISION CUP FOR THIS PATIENT ON (B)(6) 2012. HE USED A STRYKER 32MM HEAD AT THAT TIME. THE PATIENT THEN DISLOCATED AFTER THE FIRST REVISION. HE THEN USED A CONSTRAINED LINER FROM ZIMMER AND A 28MM HEAD FROM STRYKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31788 C-TAPER INTER.NK HEAD IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH MKL0VK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention