BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT ALUMINA INSERT

    MDR report key: 9727940 · Received February 19, 2020

    Report

    Report Number
    0002249697-2020-00351
    Event Type
    Injury
    Date Received
    February 19, 2020
    Date of Event
    December 1, 2011
    Report Date
    February 19, 2020
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MRA
    UDI-DI
    04546540516848
    PMA / PMN Number
    P000013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: 641150,6021-0335,ACCOLADE PLUS TMZF HIP STEM #3,SHC; CAT# 6021-0335; LOT# 36358503, 640656,500-11-52E,TRIDENT HEMISPHERICAL SOLID BACK SHELL,SHC; CAT# 500-11-52E; LOT# 36690401, 850223,6565-0-032,ALUMINA V40-FEMORAL HEAD 32MM, -4MM NK,SHC; CAT# 6565-0-032; LOT# 23923401. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE HAD A THR AND WAS IMPLANTED WITH STRYKER IMPLANTS IN (B)(6) 2011. AFTER ABOUT 6 MONTHS THE CUSTOMER NOTICED PAIN IN BUTTOCK AND THIGH. DURING FOLLOW UP WITH HER CONSULTANT HE SUGGESTED THAT MICROMOTION MIGHT BE A POSSIBLE EXPLANATION AS THIS WAS A CEMENTED STEM, BUT THAT THIS COULD NOT DEFINITIVELY BE KNOWN THE PAIN EASED OFF BUT RECENTLY HAS RETURNED AND THE PATIENT REPORTS PAIN BEHIND THE SCAR AND PAIN IS ALSO NOTICEABLE DOWN HER LEG WHEN WALKING THE PATIENT HAS HAD SUBSEQUENT X-RAYS ON HER BACK TO INVESTIGATE THE PAIN THE PATIENT IS QUESTIONING WHETHER THERE MAY BE SOME METAL INTOLERANCE UNDERLYING THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192832 TRIDENT ALUMINA INSERT PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE MRA STRYKER ORTHOPAEDICS-MAHWAH 625-0T-32E 36832201 04546540516848

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other