BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEAD 12/14 Ø 28 SIZE S -3.5

    MDR report key: 6127000 · Received November 24, 2016

    Report

    Report Number
    3005180920-2016-00610
    Event Type
    Injury
    Date Received
    November 24, 2016
    Date of Event
    October 26, 2016
    Report Date
    December 7, 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 07 NOVEMBER 2016 THE R&D PROJECT MANAGER PERFORMED A PRELIMINARY INVESTIGATION AND COMMENTED AS FOLLOWS: ONE OF THE POSSIBLE ROOT CAUSES COULD BE AN OPTIMAL PRIMARY STABILITY OF THE STEM AND A GOOD OSSEOINTEGRATION: AWAITED PHONOMENON AND CONSEQUENTLY POSITIVE. ANOTHER POSSIBLE CAUSE COULD BE THE USE OF A WRONG INSTRUMENTATION TO EXPLANT THE INVOLVED STEM (BLADES USED TO DIVIDE THE IMPLANT FROM THE BONE, STEM EXTRACTOR...). LASTLY, IT COULD NOT BE EXCLUDED THE POSSIBILITY OF A SUBOPTIMAL USE OF THE REVISION INSTRUMENTS AND/ OR A NOT CORRECT REVISION TECHNIQUE ADOPTED. THE DIFFICULTY IN EXPLANTING A WELL OSSEOINTEGRATED STEM IS WELL KNOWN, BUT IT CANNOT BE CONSIDERED AS A DEFECT OF THE IMPLANT: IN FACT, IF THE STEM IS NOT FIXED, IT WILL FAIL.

    Additional Manufacturer Narrative · 1

    THE REVISION SURGERY WAS PERFORMED IN 2 STEPS. AT FIRST, THE SURGEON RETRIEVED BIPOLAR HEAD AND FEMORAL HEAD, THEN THE SURGEON USED CEMENT SPACER MOLD WITH ANTIBIOTICS. AT SECOND STEP, THE SURGEON'S PURPOSE WAS REPLACING ALL IMPLANTS. ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON 04 NOVEMBER 2016 AND INCLUDES: THE PATHOGEN IS UNKNOWN. THE SECOND STEP OF THE REVISION WAS PERFORMED TO REMOVE THE SPACERS PUT IN DURING THE FIRST STEP AND THE NOT-EXPLANTED STEM. THE SURGEON PLANNED TO REPLACE ALL IMPLANTS WITH NEW ONES, BUT IN THE END NO IMPLANTS WERE REPLACED DUE SINCE THE STEM WAS NOT RETRIEVED FROM PATIENT BONE BECAUSE IT WAS FIXED QUITE STRONGLY. AFTER MANY ATTEMPTS, FEMORAL BONE WAS BROKEN AND IT WAS FIXED WITH A CABLE.. AN ADDITIONAL SURGERY WAS PLANNED. BATCH REVIEWS PERFORMED ON 21 NOVEMBER 2016. LOT 160025: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 MARCH 2016. EXPIRATION DATE: 2021-02-23. 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. BIPOLAR HEAD COCR Ø28X46, CODE (B)(4), LOT. 133857 (NOT MARKETED IN U.S.) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 SEPTEMBER 2014. EXPIRATION DATE: 2018-12-31. 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.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777829 COCR BALL HEAD 12/14 Ø 28 SIZE S -3.5 METALLIC BALL HEAD JDI MEDACTA INTERNATIONAL SA 160025

    Patients

    Seq Age Sex Outcome Treatment
    1 101 YR Required Intervention