BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0° X3 INSERT 36MM ID

    MDR report key: 3076670 · Received April 25, 2013

    Report

    Report Number
    0002249697-2013-01395
    Event Type
    Injury
    Date Received
    April 25, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 29, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER HIP DEVICES WERE ALSO LISTED IN THIS REPORT: SECUR-FIT MAX 127 HIP STEM #8, CAT# 6052-0830S, LOT# MMA8A3; DELTA C-TAPER HEAD 36MM +7.5, CAT# 18-3675, LOT# 36745601; TRIDENT PSL HA CLUSTER 56MM, CAT# 542-11-56F, LOT# D5PMPD; 6.5 CANCELLOUS BONE SCREW 20MM, CAT# 2030-6520-1, LOT# MJPJED; 6.5 CANCELLOUS BONE SCREW 25MM, CAT# 2030-6525-1, LOT# MJTT6N. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. (B)(4): NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A TRIDENT LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED MANUFACTURING LOT OR THE STERILITY LOT REFERENCED IN THIS EVENT. THE SOURCE OF THE INFECTION COULD NOT BE DETERMINED AS PATIENT INFORMATION, CLINICAL HISTORY, AND RESULTS OF BLOODWORK FOR INFECTION WERE NOT PROVIDED.

    Description of Event or Problem · 1

    PATIENT HAD HIP DRAINAGE AFTER HAVE AN ABG2 REVISION ON (B)(6) WITH A SECUREFIT STEM.

    Description of Event or Problem · 1

    PATIENT HAD HIP DRAINAGE AFTER HAVE AN ABG2 REVISION ON (B)(6) WITH A SECUREFIT STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178110 TRIDENT 0° X3 INSERT 36MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MMDNE2

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention