BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 X3 INSERT 36MM ID

    MDR report key: 11140422 · Received January 8, 2021

    Report

    Report Number
    0002249697-2021-00066
    Event Type
    Injury
    Date Received
    January 8, 2021
    Date of Event
    July 30, 2015
    Report Date
    January 8, 2021
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    UDI-DI
    07613327039542
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM; CAT# 502-03-54E; LOT# MNMJL8; 6.5 CANCELLOUS BONE SCREW 30MM; CAT# 2030-6530-1; LOT# 4H7A27; DELTA C-TAPER HEAD 36MM +5; CAT# 18-3605; LOT# 51825702; 6.5 CANCELLOUS BONE SCREW 20MM; CAT# 2030-6520-1; LOT# 28149T; SECUR-FIT MAX 132 HIP STEM #9; CAT# 6051-0935S; LOT# MNPD36. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT, HE HAD A RIGHT THA DONE ON (B)(6) 2015 AND A LEFT THA ON (B)(6) 2015. SINCE HE'S HAD HIS SURGERIES, PATIENT STARTED TO EXPERIENCE QUAD TIGHTNESS, PAIN, HIS LEFT FOOT TURNS IN. HE EXPERIENCES PAIN FROM HIS LOWER BACK TO HIS KNEE. HE IS EXPERIENCING CRAMPS, GROIN PAIN, OUTSIDE QUAD PAIN. HE NO LONGER HAS THE REFLEX WHEN HE TRIPS ON SOMETHING HE'LL FALL. PATIENT NOW USES A CANE. HE IS NO LONGER ACTIVE AS HE WAS BEFORE HIS SURGERIES. PATIENT WOULD LIKE TO KNOW IF HIS IMPLANTS ARE PART OF RECALL. HE WOULD LIKE TO KNOW WHY HE IS EXPERIENCING THESE SYMPTOMS. THIS PI IS FOR LEFT THA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37843 TRIDENT 0 X3 INSERT 36MM ID PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI STRYKER ORTHOPAEDICS-MAHWAH 623-00-36E 1337AW 07613327039542

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other