BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION ADM X3 INS

    MDR report key: 8627319 · Received May 21, 2019

    Report

    Report Number
    0002249697-2019-02002
    Event Type
    Injury
    Date Received
    May 21, 2019
    Date of Event
    April 24, 2019
    Report Date
    July 24, 2019
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    UDI-DI
    04546540665898
    PMA / PMN Number
    K103233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING METALLOSIS CAUSED BY MALPOSITIONED IMPLANTS RESULTING IN IMPINGEMENT WAS REPORTED. CONCLUSION BASED ON THE INFORMATION PROVIDED THERE IS NO INDICATION OR ALLEGATION THAT THE DEVICE REPORTED IN THIS INVESTIGATION CONTRIBUTED TO THE EVENT AND IS THEREFORE CONSIDERED CONCOMITANT. THE ADM LINER COMPONENT IS A POLYETHYLENE COMPONENT LOCATED WITHIN THE MDM LINER, THE REPORTED EVENT IS REGARDING METALLOSIS CAUSED BY MALPOSITIONED IMPLANTS RESULTING IN IMPINGEMENT, THE POLYETHYLENE ADM LINER COMPONENT WOULD NOT HAVE BEEN IN A POSITION TO GENERATE METAL DEBRIS TO CAUSE THE REPORTED METALLOSIS. THE DEVICE ALSO DOES NOT INTERFACE WITH THE PATIENTS BONE, IT IS FIXED WITHIN THE MDM LINER AND HENCE, COULD NOT BE MALPOSITIONED. A FULL INVESTIGATION IS COMPLETED ON BONE INTERFACING COMPONENTS - TRIDENT TRITANIUM SHELL AND UNKNOWN STEM WHICH MAY HAVE BEEN MALPOSITIONED RESULTING IN IMPINGEMENT AND ALSO THE METAL MDM LINER (PR 2071533) WHICH MAY HAVE IMPINGED WITH THE STEM RESULTING IN METALLIC FRETTING DEBRIS WITHIN THE SAME PI. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    AS REPORTED: "CUP, HEAD, LINERS REMOVED DUE TO METALLOSIS CAUSED BY MALPOSITIONED IMPLANTS RESULTING IN IMPINGEMENT".

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    AS REPORTED: "CUP, HEAD, LINERS REMOVED DUE TO METALLOSIS CAUSED BY MALPOSITIONED IMPLANTS RESULTING IN IMPINGEMENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420584 RESTORATION ADM X3 INS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO STRYKER ORTHOPAEDICS-MAHWAH 282099 04546540665898

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R