BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 46MM

    MDR report key: 3781105 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01714
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 18, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K081171
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE HOSPITAL AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DISLOCATION INVOLVING A TRITANIUM SHELL WAS REPORTED. THE EVENT WAS NOT CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF ALL AVAILABLE MEDICAL RECORDS WAS COMPLETED BY A CLINICAL CONSULTANT. THE CLINICIAN COULD NOT CONFIRM THE EVENT, MEDICAL RECORDS, CLINICAL HISTORY AND PROGRESS NOTES ARE NEEDED TO FURTHER INVESTIGATE DEVICE HISTORY REVIEW: REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: 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 OPERATIVE REPORTS, PROGRESS NOTES, FURTHER X-RAYS AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS DISLOCATING DUE TO ABDUCTORS AVULSING FROM GREATER TROCH. REVISED 46 MM CUP IN ORDER TO IMPLANT A 52 MM CUP THAT WOULD ACCEPT A CONSTRAINED LINER. IMPLANTED A 52MM TRIDENT HEMISPHERICAL MULTIHOLE CUP WITH A 6.5MM X 50MM SCREW AND A 6.5 X 20MM SCREW, A TRIDENT 0 DEGREE E CONSTRAINED LINER AND A 22MM + 5 HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS DISLOCATING DUE TO ABDUCTORS AVULSING FROM GREATER TROCH. REVISED 46 MM CUP IN ORDER TO IMPLANT A 52 MM CUP THAT WOULD ACCEPT A CONSTRAINED LINER. IMPLANTED A 52MM TRIDENT HEMISPHERICAL MULTIHOLE CUP WITH A 6.5MM X 50MM SCREW AND A 6.5 X 20MM SCREW, A TRIDENT 0 DEGREE E CONSTRAINED LINER AND A 22MM + 5 HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259912 PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 46MM IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MMD2AP

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention