BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IC-BIPOLAR HEAD COCRMO Ø28/46

    MDR report key: 11035224 · Received December 18, 2020

    Report

    Report Number
    3012523063-2020-00015
    Event Type
    Injury
    Date Received
    December 18, 2020
    Report Date
    February 17, 2020
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    LZO
    PMA / PMN Number
    K180263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE OPTICAL EXAMINATIONS SHOWED NO SIGNIFICANT SIGNS OF DAMAGE ON THE PARTS (FIGURES ATTACHED). FURTHERMORE, THROUGH A FUNCTIONAL TEST IT COULD BE DETERMINED, THAT THE PARTS FIT TOGETHER AS THEY ARE INTENDED TO. IT COULD NOT BE TESTED HOW FIRM THE BIOLOX® HEAD IS SEATED INSIDE THE BIPOLAR HEAD WITHOUT RISKING FURTHER DAMAGE ON THE PARTS. THE PRODUCTION DOCUMENTS AND MATERIAL CERTIFICATIONS ARE FLAWLESS AND SHOW NO DEVIATIONS. FURTHERMORE, THE IMPLANTCAST GMBH WAS PROVIDED WITH AN X-RAY THAT WAS MADE PRIOR TO THE REVISION. IT IS VISIBLE THAT THE HEAD IS NOT ONLY DISLOCATED BUT ALSO DISCONNECTED. IT IS SUSPECTED THAT THE DISLOCATION HAPPENED FIRST AND AFTERWARDS THE DISCONNECTION. IT IS FURTHER SUSPECTED THAT THE DISLOCATION IS PATIENT-RELATED BECAUSE BASED ON THE EXAMINATION THERE IS NO PRODUCT FAILURE OR TECHNICAL ERROR RECOGNISABLE, BUT THIS CANNOT BE ESTABLISHED WITH ABSOLUTE CERTAINTY.

    Description of Event or Problem · 0

    ON 04.12.2020 THE IMPLANTCAST GMBH RECEIVED THE MESSAGE THAT AN IC- BIPOLAR HEAD DISLOCATED OUT OF THE NATURAL ACETABULUM AFTER BEING IMPLANTED FOR ABOUT 1 YEAR. ON 18TH OF JANUARY 2021 THE IMPLANTCAST GMBH RECEIVED THE FORMERLY IMPLANTED PRODUCTS.

    Additional Manufacturer Narrative · 1

    SINCE THE IMPLANTCAST (B)(4) WAS PROVIDED WITH NEITHER THE PRODUCTS, NOR PICTURES AN OPTICAL INSPECTION WAS NOT POSSIBLE. FOR THE SAME REASONS AN ASSESSMENT OF THE DIMENSIONAL ACCURACY AS WELL AS A FUNCTIONAL TESTING AND AN EXTERNAL SURVEY COULD NOT BE CARRIED OUT. THE PRODUCTION DOCUMENTS AND MATERIAL CERTIFICATIONS ARE FLAWLESS AND SHOW NO DEVIATIONS. FURTHERMORE, THE IMPLANTCAST (B)(4) WAS PROVIDED WITH AN X-RAY THAT WAS MADE PRIOR TO THE REVISION. IT IS VISIBLE THAT THE HEAD IS NOT ONLY DISLOCATED BUT ALSO DISCONNECTED. IT IS SUSPECTED THAT THE DISLOCATION HAPPENED FIRST AND AFTERWARDS THE DISCONNECTION. IT IS FURTHER SUSPECTED THAT THE DISLOCATION IS PATIENT-RELATED BECAUSE TO OUR KNOWLEDGE THERE IS NO PRODUCT FAILURE OR TECHNICAL ERROR RECOGNISABLE, BUT THIS CANNOT BE ESTABLISHED WITH ABSOLUTE CERTAINTY.

    Description of Event or Problem · 1

    ON (B)(6) 2020 THE IMPLANTCAST (B)(4) RECEIVED THE MESSAGE THAT AN IC- BIPOLAR HEAD DISLOCATED OUT OF THE NATURAL ACETABULUM AFTER BEING IMPLANTED FOR ABOUT 1 YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504147 IC-BIPOLAR HEAD COCRMO Ø28/46 LZO IMPLANTCAST GMBH 21510046

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R IC-HEAD BIOLOX® REF:25872800 LOT: 7011227992| IC-HEAD BIOLOX® REF:25872800 LOT: 7011227992| IC-HEAD BIOLOX® REF:25872800 LOT: 7011227992