BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: COCR BALL HEAD 12/14 Ø 32 SIZE M 0

    MDR report key: 8503595 · Received April 11, 2019

    Report

    Report Number
    3005180920-2019-00273
    Event Type
    Injury
    Date Received
    April 11, 2019
    Date of Event
    March 15, 2019
    Report Date
    April 25, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805165
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: REVISION DUE TO PRIMARY MOBILIZATION. IMPLANT ALMOST INTACT AS NEW. NO-IMPLANT RELATED FAILURE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: HIP DISLOCATION FEW DAYS AFTER PRIMARY IMPLANTATION. ACCORDING TO THE REPORT, THIS EVENT OCCURRED WHILE MOVING IN BED. HIP DISLOCATION MAY BE DUE TO COMPONENT POSITIONING OR INSUFFICIENT SOFT TISSUE TENSIONING; IT CAN HARDLY BE CAUSED BY STANDARD DEVICES. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: REVISION DUE TO PRIMARY MOBILIZATION. IMPLANT ALMOST INTACT AS NEW. NO-IMPLANT RELATED FAILURE ROOT CAUSE. BATCH REVIEW PERFORMED ON 08 APRIL 2019: LOT 186282: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-DEC-2018. EXPIRATION DATE: 2023-12-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL COMPONENTS INVOLVED: STEM: AMISTEM H 01.18.173 AMISTEM-H PROXIMAL COATING STD STEM SIZE 3 (K161635), LOT 184654: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-NOV-2018. EXPIRATION DATE: 2023-10-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. LINER: CC E CC LIGHT 01.26.3244HCT FLAT PE HC LINER Ø 32 / E (K103352), LOT 187111: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-NOV-2018. EXPIRATION DATE: 2023-10-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THREE WEEKS AFTER PRIMARY SURGERY, THE PATIENT MOVED IN BED SO THERE WAS A LUXATION OF THE HIP. THE HEAD DISLOCATED FROM THE LINER. IN ADDITION TO THE LUXATION, THE STEM GOT TURNED/ROTATED. THE STEM WAS REPLACED BY AN AMISTEM-C. HEAD WAS REPLACED AS WELL. PRIMARY SURGERY WAS IN AMIS. THE BONE QUALITY WAS NOT SO GOOD, IN PARTICULAR ON THE PROXIMAL PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295620 BALL HEADS: COCR BALL HEAD 12/14 Ø 32 SIZE M 0 METAL FEMORAL BALL HEAD JDI MEDACTA INTERNATIONAL SA 186282 07630030805165

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention