BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNWON PRODUCT (LRG TAP PRI MOD NCK 0DEG 30MM)

    MDR report key: 2851202 · Received November 26, 2012

    Report

    Report Number
    9616680-2012-01174
    Event Type
    Injury
    Date Received
    November 26, 2012
    Date of Event
    October 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JDI
    PMA / PMN Number
    K092561
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    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. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. SHOULD DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE ATTORNEY FOR THE PATIENT, AS A RESULT OF A LEGAL CLAIM, THAT ALLEGEDLY THE PATIENT IS HAVING PROBLEMS WITH HER IMPLANT WHICH INCLUDE BUT ARE NOT LIMITED TO SEVERE PAIN IN THE AREA OF HER RIGHT HIP AND OTHER AREAS OF HER BODY, UNSAFE LEVELS OF A METAL OR METALS IN HER BODY AND OTHER PHYSICAL PROBLEMS. IT IS FURTHER ALLEGED THAT HER MEDICAL PROVIDERS HAVE OPINED THAT THE PRODUCT IMPLANTED IN (B)(6) 2007 NEEDS TO BE REMOVED DUE TO PHYSICAL PROBLEMS/CONDITIONS WHICH STEM FROM THE PRODUCT. ADDITIONAL INFORMATION PROVIDED BY SALES REP ON (B)(6) 2012: DOCTOR REVISED PATIENT'S RIGHT HIP DUE TO ADVERSE LOCAL TISSUE REACTION ALTR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNWON PRODUCT (LRG TAP PRI MOD NCK 0DEG 30MM) IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA 23282601

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention