BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-10968

    MDR report key: 3010969 · Received March 8, 2013

    Report

    Report Number
    2520274-2013-10968
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    January 3, 2012
    Report Date
    January 1, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEB 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS.(B)(4)

    Additional Manufacturer Narrative · 1

    CONTACT NAME CHANGED TO (B)(6) MANAGER. IN THE FU#1 REPORT, SHOULD HAVE BEEN REPORTED AS (B)(6) 2012.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE PT 2 MONTHS STATUS POST TROCHANTERIC FIXATION NAIL PROCEDURE PRESENTS TO ER ON THE EVENING OF (B)(6) 2012, COMPLAINING OF HIP PAIN. X-RAYS REVEALED THAT THE HELICAL BLADE HAD MIGRATED OUT OF THE FEMORAL HEAD. PT WAS RETURNED TO OPERATING ROOM ON (B)(6) 2012, WHERE DR MCCALL EXPLANTED THE NAIL, BLADE AND LOCKING SCREW. THE PT WAS REVISED TO A HEMIARTHROPLASTY. SURGEON NOTED LOSS OF REDUCTION AND CUTOUT OF HELICAL BLADE INTO ACETABULA. PT WAS CONVERTED TO TOTAL HIP ARTHROPLASTY (THA).

    Description of Event or Problem · 1

    THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100483 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention