BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR HEAD Ø 28X48

    MDR report key: 5991536 · Received September 30, 2016

    Report

    Report Number
    3005180920-2016-00498
    Event Type
    Injury
    Date Received
    September 30, 2016
    Date of Event
    August 31, 2016
    Report Date
    September 30, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWY
    PMA / PMN Number
    K091967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: 1,5 MONTHS AFTER CEMENTLESS PARTIAL ARTHROPLASTY A DISLOCATION OCCURRED, ACCORDING TO REPORT, WITH NO TRAUMATIC EVENT. THE LOW-QUALITY RADIOGRAPH SUPPLIED SHOWS A SUNKEN STEM, POSSIBLY UNDERSIZED, ALTHOUGH CONTRALATERAL HIP IS NOT REPRESENTED AND THEREFORE FULL EVALUATION IS NOT POSSIBLE. THE CONDITION THAT MAY LEAD TO INTERPROSTHETIC DISLOCATION WITH THE USE OF A BIPOLAR HEAD IS HARD TO IMAGINE: A POSSIBLE SCENARIO IS THAT THE SMALL COCR HEAD HAD NOT BEEN FULLY INSERTED IN THE BIPOLAR COMPONENT AT PRIMARY OPERATION. THIS SHOULD BE DETECTABLE FROM A POSTOPERATIVE X-RAY, NOT AVAILABLE. NO OTHER HYPOTHESIS CAN BE FORMULATED AT PRESENT WITH THE SUPPLIED INFORMATION. BATCH REVIEWS PERFORMED ON (B)(6) 2016. LOT 153707: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 OCTOBER 2015. EXPIRATION DATE: 2020-10-06. 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. COCR BALL HEAD 12/14 Ø 28 SIZE S-3.5, CODE (B)(4), LOT. 151900 (K072857); (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 JUNE 2015. EXPIRATION DATE: 2020-05-31. 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. NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT DISLOCATED HIS HIP. THE DISLOCATION WAS CAUSED BY CROSSING HIS LEG. THE SURGEON REVISED THE COCR HEAD AND THE BIPOLAR HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643787 BIPOLAR HEAD Ø 28X48 BIPOLAR HEAD KWY MEDACTA INTERNATIONAL SA 153707

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention