BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG X3 INSERT 32MM HEAD

    MDR report key: 8568698 · Received May 1, 2019

    Report

    Report Number
    0002249697-2019-01792
    Event Type
    Injury
    Date Received
    May 1, 2019
    Date of Event
    November 1, 2018
    Report Date
    May 1, 2019
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    UDI-DI
    07613327039467
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: TRIDENT PSL HA CLUSTER 48MM; CAT#542-11-48D; LOT# 54692401. DELTA C-TAPER HEAD 36MM -5; CAT# 18-36-5; LOT# 60429403. TI SLEEVE FOR ALUMINA HEAD; CAT# 17-0000E; LOT# RE7PTD. 6.5 CANCELLOUS BONE SCREW 20MM; CAT# 2030-6520-1; LOT# T12VH1. GAP PLATE SCREWS; CAT# 2080-0040; LOT# K23709. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THAT DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    POSTOPERATIVE DIAGNOSIS: PATIENT UNDERWENT RIGHT TOTAL HIP REPLACEMENT (B)(6) 2016. PATIENT HAD SEVERE PAIN AFTER HIP REPLACEMENT (ILIOPSOAS TENDINITIS). NO EVIDENCE OF INFECTION. THE HEAD AND LINER WERE REMOVED. FEMORAL COMPONENT AND ACETABULAR WERE RETAINED (B)(6) 2017. PATIENT HAD DEVELOPED SIGNIFICANT PAIN AFTER REVISION. NOW ALL COMPONENTS WERE EXCHANGED EXCEPT STEM IN (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363614 TRIDENT 0 DEG X3 INSERT 32MM HEAD PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 3N585K 07613327039467

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R