BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM +4 LFIT V40 HEAD

    MDR report key: 7174937 · Received January 9, 2018

    Report

    Report Number
    0002249697-2018-00086
    Event Type
    Injury
    Date Received
    January 9, 2018
    Date of Event
    August 19, 2017
    Report Date
    March 20, 2020
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K173499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: UPDATE TO DEVICE INFORMATION AN EVENT REGARDING DISLOCATION INVOLVING A LFIT V40 HEAD WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS NO PRODUCT WAS RETURNED FOR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS PERTAINING TO THIS EVENT WERE PROVIDED. DEVICE HISTORY REVIEW: INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN THREE OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. PR 1693161, PR 1693164 AND PR 1781852 ALL RELATE TO THE SAME PATIENT FOR DISLOCATION. CONCLUSIONS: THE EVENT ITSELF COULD NOT BE CONFIRMED AND EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS DEVICE RETURN, PRE AND POST OPERATIVE X-RAYS, OPERATIVE REPORTS AS WELL AS PATIENT HISTORY AND FOLLOW UP NOTES ARE REQUIRED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    AS REPORTED IN (B)(4): "SIXTH DISLOCATION - RIGHT HIP". DISLOCATION REPORTED AFTER 06/24/2013 REVISION.

    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. NOT AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED IN MW5072177: "SIXTH DISLOCATION - RIGHT HIP". DISLOCATION REPORTED AFTER (B)(6) 2013 REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21088 32MM +4 LFIT V40 HEAD PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI STRYKER ORTHOPAEDICS-MAHWAH 36628304

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other