BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEAD 12/14 Ø 28 SIZE M 0

    MDR report key: 5778952 · Received July 8, 2016

    Report

    Report Number
    3005180920-2016-00338
    Event Type
    Injury
    Date Received
    July 8, 2016
    Date of Event
    June 8, 2016
    Report Date
    July 8, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 04 JULY 2016 THE (B)(4) PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: DAY 1 DISLOCATION IN THA IS A POSSIBLE ADVERSE EVENT, WHICH NORMALLY COMES FROM DIFFICULTIES IN ACHIEVING EITHER A SATISFACTORY RELATIVE POSITION OF THE COMPONENTS OR INSUFFICIENT SOFT-TISSUE TENSION. IN THIS CASE, NO INFORMATION IS AVAILABLE IN TERMS OF X-RAYS OR FURTHER INTRA-OPERATIVE DETAILS. REPLACEMENT OF THE HEAD WITH A LONGER-NECK ONE SUGGESTS THAT INSUFFICIENT SOFT-TISSUE TENSION HAD BEEN ACHIEVED AT PRIMARY OPERATION. WHETHER THIS IS DUE TO STEM SUBSIDENCE OR CUP MIGRATION OR TO A PROBLEM IN INTRA-OPERATIVE TENSION ASSESSMENT IS UNKNOWN, BUT IS VERY UNLIKELY TO BE ATTRIBUTED TO A DEFECTIVE DEVICE. BATCH REVIEW PERFORMED ON 05 JULY 2016. LOT 151904: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 AUGUST 2015. EXPIRATION DATE: 2020-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ON 08 JULY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION SUBMITTED IN THIS INITIAL REPORT. ON THE SAME DATE THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    AFTER THE SURGERY, THE SURGEON FOUND DISLOCATION. HE IMMEDIATELY PERFORMED REVISION SURGERY AND REPLACED THE FEMORAL HEAD WITH MORE LARGER SIZE. EXPLANTS AND X-RAYS ARE NOT AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433300 COCR BALL HEAD 12/14 Ø 28 SIZE M 0 METALLIC BALL HEAD JDI MEDACTA INTERNATIONAL SA 151904

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention