BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG INSERT 36MM

    MDR report key: 9087577 · Received September 19, 2019

    Report

    Report Number
    0002249697-2019-03269
    Event Type
    Injury
    Date Received
    September 19, 2019
    Date of Event
    April 10, 2019
    Report Date
    September 19, 2019
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    UDI-DI
    07613327025309
    PMA / PMN Number
    K062419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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.. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: PRIMARY TRITANIUM HEMI SOLIDBACK CUP 52MM, CAT#500-03-52D, LOT# MLTY80. V40 COCR LFIT HEAD 36MM/0, CAT#6260-9-136, LOT#MLND6A. 1074688,6721-0737,SIZE 7 ACCOLADE II 127 DEG, SHC, CAT# 6721-0737, LOT#42425505. 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

    PATIENT IS PART OF THE TRITANIUM PRIMARY ACETABULAR SHELL STUDY AND REPORTED PAIN IN THE STUDY HIP DURING THE 6-YEAR VISIT. PATIENT FEELS STRONGLY THAT PAIN IS RELATED TO OTHER ISSUES SUCH AS SACROILIAC JOINT, KNEES AND FIBROMYALGIA. OPERATIVE SIDE IS LEFT. PATIENT HAS NOT BEEN REVISED AS OF THE DATE OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884252 TRIDENT 0 DEG INSERT 36MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH MMAP5H 07613327025309

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other