BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM

    MDR report key: 4210958 · Received October 29, 2014

    Report

    Report Number
    0002249697-2014-04049
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 3, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K081171
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(6). AN EVENT REGARDING PAIN AND CUP LOOSENING INVOLVING A TRIDENT TRITANIUM SHELL WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION OBSERVED EXPLANTATION DAMAGE AND NO BONE INGROWTH PRESENT ON THE SHELL. -MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. PRE- AND POST OPERATIVE X-RAYS, A COMPLETE REVISION OPERATIVE REPORT AND FINDINGS, AND PROGRESS NOTES ARE NEEDED FOR FURTHER CLINICIAN REVIEW. -DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION, INCLUDING REVISION OPERATIVE REPORTS AND FINDINGS, PRE AND POST OPERATIVE X-RAYS, AND PROGRESS NOTES IS NEEDED TO FULLY INVESTIGATE THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD HIP REVISED DUE TO GROIN PAIN AND LOOSE CUP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD HIP REVISED DUE TO GROIN PAIN AND LOOSE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691943 PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MMN2TY

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention