BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECUR-FIT MAX 127 #11

    MDR report key: 3911958 · Received July 3, 2014

    Report

    Report Number
    0002249697-2014-02538
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    December 1, 2013
    Report Date
    June 9, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K051738
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN RIGHT STRYKER HIP. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING INFECTION INVOLVING A SECUR-FIT MAX STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF MEDICAL RECORDS COULD NOT CONFIRM THE REPORTED INFECTION. DEVICE HISTORY REVIEW: RECORDS INDICATE THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED STERILE LOT OR LOT IDS. CONCLUSIONS: THE SOURCE OF THE INFECTION COULD NOT BE CONFIRMED IN PROVIDED MEDICAL RECORDS. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INFECTION IS MOST LIKELY A RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE IN THE HEALTHCARE FACILITY SETTING. THE FOLLOWING OTHER DEVICES WERE ALSO LISTED IN THIS REPORT: TRIDENT PSL HA CLUSTER 54MM; CAT# 542-11-54F; LOT# MLN7W1; TRIDENT 10° X3 INSERT 36MM ID; CAT# 623-10-36F; LOT# MLH51P; DELTA C-TAPER HEAD 36MM +5; CAT# 18-3605; LOT# 39665601; D-M 1.6MM BEADED CABLE SET SS; CAT# 3704-0-040; LOT# 40036702; D-M 1.6MM BEADED CABLE SET SS; CAT# 3704-0-040; LOT# 38817001. 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

    IT WAS REPORTED THAT THE PATIENT IS STILL IN CONSTANT PAIN AFTER REVISION SURGERY. CT SCAN SHOWED FLUID BUILDUP AND INFECTION. DOCTOR DRAINED THE FLUID. PATIENT ALSO DID ANOTHER SCAN TO SEE IF COMPONENT IS LOOSED, HE IS STILL AWAITING RESULTS. HE IS ON PAIN KILLER AND STILL WALKS ON CRUTCHES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS STILL IN CONSTANT PAIN AFTER REVISION SURGERY. CT SCAN SHOWED FLUID BUILDUP AND INFECTION. DOCTOR DRAINED THE FLUID. PATIENT ALSO DID ANOTHER SCAN TO SEE IF COMPONENT IS LOOSED HE IS STILL AWAITING RESULTS. HE IS ON PAIN KILLER AND STILL WALKS ON CRUTCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389773 SECUR-FIT MAX 127 #11 IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH MLDA9J

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other