BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRYKER HIP

    MDR report key: 8204659 · Received December 28, 2018

    Report

    Report Number
    0002249697-2018-04183
    Event Type
    Injury
    Date Received
    December 28, 2018
    Date of Event
    September 6, 2018
    Report Date
    November 23, 2020
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IT WAS DISCOVERED THAT THE SELECTION FOR B2 WAS INADVERTENTLY MISSED DURING THE SUBMISSION OF THE INITIAL REPORT. B2 HAS BEEN UPDATED WITH THE APPROPRIATE INFORMATION.

    Description of Event or Problem · 0

    QUARTERLY REPORT RECEIVED AS PART OF THE 2012-024 IIS (CLINICAL AND RADIOGRAPHIC OUTCOME OF THE STRYKER REJUVENATE STUDY) REVEALED PATIENT ID: CHL1718 UNDERWENT REVISION ON 09/06/2018. VERY LIMITED INFORMATION IS INCLUDED IN THE QUARTERLY REPORT AND AN E-MAIL HAS BEEN SENT OUT TO SURGEON AND THE SALES REP AS AN ATTEMPT TO GET MORE INFORMATION. UPDATE 10/DECEMBER/2018: SURGEON PROVIDED ADDITIONAL INFORMATION: "[PATIENT] HAD A REJUVENATE REVISED YEARS AGO AT ANOTHER INSTITUTION BUT WAS DISLOCATING SO THE REVISION WAS FOR INSTABILITY..."

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    QUARTERLY REPORT RECEIVED AS PART OF THE (B)(6) REVEALED PATIENT ID: (B)(6) UNDERWENT REVISION ON (B)(6) 2018. VERY LIMITED INFORMATION IS INCLUDED IN THE QUARTERLY REPORT AND AN E-MAIL HAS BEEN SENT OUT TO SURGEON AND THE SALES REP AS AN ATTEMPT TO GET MORE INFORMATION. UPDATE 10/DECEMBER/2018: SURGEON PROVIDED ADDITIONAL INFORMATION: "[PATIENT] HAD A REJUVENATE REVISED YEARS AGO AT ANOTHER INSTITUTION BUT WAS DISLOCATING, SO THE REVISION WAS FOR INSTABILITY..."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044038 UNKNOWN STRYKER HIP HIP IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R