BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM

    MDR report key: 6096818 · Received November 11, 2016

    Report

    Report Number
    0002249697-2016-03570
    Event Type
    Injury
    Date Received
    November 11, 2016
    Date of Event
    January 7, 2016
    Report Date
    January 19, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K143085
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING LOOSENING INVOLVING AN TRITANIUM SHELL WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE DEVICE WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT CONCLUDED: "THE PRIMARY HARM INVOLVED IS ASEPTIC LOOSENING OF A THA ACETABULAR IMPLANT. NO OBVIOUS CAUSE FOR THIS COMPLICATION WAS REPORTED. FURTHER DOCUMENTATION REQUIRED FOR COMPLETION OF THIS ASSESSMENT." DEVICE HISTORY REVIEW: DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES COMPLAINT HISTORY REVIEW: THERE HAS BEEN NO OTHER EVENT FOR THE LOT REFERENCED. CONCLUSIONS: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT CONCLUDED THAT THE PRIMARY HARM INVOLVED IS ASEPTIC LOOSENING OF A ACETABULAR IMPLANT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED LOOSENING MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE. FURTHER INFORMATION SUCH AS RETURN OF DEVICE, PRE AND POST OP XRAYS FROM THE INDEX SURGERY AND OUTPATIENT OFFICE/CLINIC NOTES ARE NEEDED TO DETERMINE THE ROOT CAUSE. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO LOOSENING OF ACETABULAR COMPONENT.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO LOOSENING OF ACETABULAR COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748875 PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH N2895D

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R