BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCA LOW PROF ACET/CUP 32X49MM

    MDR report key: 2942392 · Received February 4, 2013

    Report

    Report Number
    0002249697-2013-00556
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 15, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K831373
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE DEVICE HISTORY RECORDS COULD NOT BE LOCATED. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. INSUFFICIENT MEDICAL RECORDS WERE RECEIVED FOR REVIEW AS MEDICAL HISTORY, PROGRESS/CONSULTATION NOTES, AND OPERATIVE REPORTS WERE DEEMED NECESSARY. THE EVENT COULD NOT BE CONFIRMED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS RECEIVED TO CONFIRM THE REPORTED EVENT. IF THE REPORTED DEVICES, X-RAYS, MEDICAL RECORDS, AND OPERATIVE REPORTS WERE MADE AVAILABLE, THEY COULD HELP IN DETERMINING THE ROOT CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE HOSPITAL AND WAS NOT RETURNED TO THE MANUFACTURER. 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. (B)(4): NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    REVISION OF THA DUE TO OSTEOLYSIS.

    Description of Event or Problem · 1

    REVISION OF THA DUE TO OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47059 PCA LOW PROF ACET/CUP 32X49MM IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH OFCSAA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention