BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN 50MM PSL CUP

    MDR report key: 6022098 · Received October 12, 2016

    Report

    Report Number
    0002249697-2016-03214
    Event Type
    Injury
    Date Received
    October 12, 2016
    Date of Event
    September 15, 2016
    Report Date
    December 29, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. INFORMATION RECEIVED INDICATED THAT NO OTHER INFORMATION IS AVAILABLE DUE TO HOSPITAL POLICY. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING WEAR INVOLVING AN UNKNOWN SHELL WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: DEVICE WAS NOT RETURNED HOWEVER, PROVIDED EXPLANTED IMAGES SHOW SCRATCHES ON THE BOTTOM OF THE RIM AND BONE ON GROWTH ON THE SHELL. MEDICAL RECORDS RECEIVED AND EVALUATION: THE PROVIDED MEDICAL RECORDS WERE DEEMED INSUFFICIENT AND REJECTED FOR MEDICAL REVIEW. HOWEVER, THE CLINICIAN NOTED THAT THE X-RAY CONFIRMS WORN LINER AFTER 25 YEARS, NOT NECESSARILY LOOSENING. CONCLUSIONS: INSPECTION OF THE PROVIDED EXPLANTED IMAGES SHOWS SCRATCHES ON THE BOTTOM OF THE RIM AND BONE ON GROWTH ON THE SHELL. THE IMAGES ALSO SHOWED THAT THE INSERT IS WORN. THE CLINICIAN WAS ABLE TO CONFIRM LINER WEAR RATHER THAN LOOSENING BASED OFF OF THE X-RAY IMAGE HOWEVER, THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS OPERATIVE REPORTS, CLINICAL AND PAST MEDICAL HISTORY, DATED X-RAYS AND EXAMINATION OF EXPLANTED COMPONENTS ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT CAME INTO SURGEON'S OFFICE WITH PAIN. SHE HAD A COMPLAINT OF SUBLUXATION. UPON X-RAY SURGEON NOTICED RADIOLUCENCY. HE ALSO NOTICED RADIOLUCENCY IN THE PROXIMAL FEMUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT CAME INTO SURGEON'S OFFICE WITH PAIN. SHE HAD A COMPLAINT OF SUBLUXATION. UPON X-RAY SURGEON NOTICED RADIOLUCENCY. HE ALSO NOTICED RADIOLUCENCY IN THE PROXIMAL FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671057 UNKNOWN 50MM PSL CUP HIP IMPLANT JDG STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention