BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN SUPRAPECTINEAL QUADRILATERAL SURFACE PLATE

    MDR report key: 9936234 · Received April 8, 2020

    Report

    Report Number
    0008031020-2020-01157
    Event Type
    Death
    Date Received
    April 8, 2020
    Date of Event
    June 23, 2014
    Report Date
    April 7, 2020
    Manufacturer
    STRYKER GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT HAS BEEN REPORTED DURING A LITERATURE REVIEW PERFORMED BY THE POST MARKET SURVEILLANCE GROUP. THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION IS AVAILABLE. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE AFFECTED LOT NUMBER WAS NOT COMMUNICATED. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED. DEVICE DISPOSITION IS UNKNOWN.

    Description of Event or Problem · 1

    THE MANUFACTURER BECAME AWARE OF A PMCF FROM (B)(6) UNIVERSITY HOSPITALS (B)(6). THE TITLE OF THIS REPORT IS ¿A RETROSPECTIVE DATA COLLECTION OF THE TREATMENT OF PELVIS AND ACETABULUM FRACTURES WITH THE STRYKER SUPRAPECTINEAL PLATE SYSTEM¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿PRO¿ SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED FROM 23 JUNE 2014 TO 29 OCTOBER 2018. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE/PATIENT DETAILS FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 10 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES DEATH. (ONE PATIENT DIED OVER A YEAR POSTOPERATIVELY BUT THERE IS NO INFORMATION AVAILABLE ABOUT WHETHER THIS AE WAS CAUSAL TO DEATH). CAUSE AND THE DATE OF THE DEATH IS UNKNOWN AND WILL NOT BE DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402278 UNKNOWN SUPRAPECTINEAL QUADRILATERAL SURFACE PLATE IMPLANT HRS STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death