BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEAD 12/14 Ø 28 SIZE M 0

    MDR report key: 6662721 · Received June 23, 2017

    Report

    Report Number
    3005180920-2017-00327
    Event Type
    Injury
    Date Received
    June 23, 2017
    Date of Event
    May 24, 2017
    Report Date
    June 23, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 16 JUNE 2017 THE MEDICAL AFFAIRS PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: FEW MONTHS AFTER PARTIAL ARTHROPLASTY IN A YOUNG PATIENT THE BIPOLAR HEAD WAS REPLACED BECAUSE OF PAIN. THE PRIMARY DIAGNOSIS IS NOT KNOWN; THE CHOICE OF A BIPOLAR HEAD IN A (B)(6) YEAR OLD PATIENT IS EXTREMELY UNUSUAL. THE ACETABULA OF THE PATIENT LOOK ARTHRITIC AND THEREFORE THE CHOICE IS NOT IMMEDIATELY UNDERSTANDABLE; THERE MAY HAVE BEEN OTHER MEDICAL CONDITIONS NOT REPORTED TO US. NO REASON TO SUSPECT THAT A FAULTY DEVICE ORIGINATED THE PROBLEM. BATCH REVIEWS PERFORMED ON 20 JUNE 2017. LOT 163204: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 JULY 2016. EXPIRATION DATE: 2021-07-11. 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 Ø28X46, CODE 25060.2846, LOT. 157153 (K091967) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 MARCH 2016. EXPIRATION DATE: 2021-02-06. 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. NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF LEFT HIP AND GROIN PAIN. THE CAUSE OF THE PAIN IS UNKNOWN AT THIS TIME. THE SURGEON REVISED THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445558 COCR BALL HEAD 12/14 Ø 28 SIZE M 0 METALLIC BALL HEAD JDI MEDACTA INTERNATIONAL SA 163204

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention