BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS HUMERAL HEAD 52 MM X 19 MM

    MDR report key: 15059520 · Received July 19, 2022

    Report

    Report Number
    3000931034-2022-00261
    Event Type
    Injury
    Date Received
    July 19, 2022
    Date of Event
    June 22, 2022
    Report Date
    July 19, 2022
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    UDI-DI
    03700386915574
    PMA / PMN Number
    K012212
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD BE CONFIRMED. THE DEVICE WAS NOT RETURNED. X-RAYS WERE PROVIDED FOR THE DEVICE. SINCE DATA WAS PROVIDED, THE OPINION OF A MEDICAL EXPERT WAS SOUGHT AND STATED AS FOLLOWS: BASED ON MY REVIEW, THERE ARE ADDITIONAL INSTANCES WHICH COULD HAVE CAUSED THE LOOSE GLENOID COMPONENT OUTSIDE OF THE PATIENT FALLING OFF A BICYCLE. THE PRESENCE OF A LOW-GRADE PERIPROSTHETIC JOINT INFECTION (PJI) WITH C. ACNES, MAY HAVE CAUSE SOME BONE RESORPTION PRIOR TO THE FALL. IT IS HOWEVER NOT SURE IF THIS WAS THE CASE SINCE THE POSITIVE ASPIRATION MAY HAVE BEEN BASED ON CONTAMINATION DURING THE ASPIRATION PROCEDURE. IF, HOWEVER, THIS ASSUMED PJI HAS WEAKENED THE FIXATION OF THE GLENOID COMPONENT, FALLING OF THE BICYCLE MAY HAVE CAUSED FURTHER LOOSENING (ACUTE ON CHRONIC) OF THE GLENOID COMPONENT, MAKING IT SYMPTOMATIC. MORE CONSISTENT CONFIRMATION OF THE PJI CAN BE ACHIEVED BY LOOKING AT THE TISSUE CULTURE SAMPLES THAT WERE MOST LIKELY TAKEN DURING THE REVISION SURGERY. THE SURGEON HAS TREATED THE CASE AS HAVING A PJI, AS SHOWN BY THE REMOVAL OF ALL PROSTHETIC COMPONENT AND REPLACING THEM WITH AN ANTIBIOTICS-LOADED SPACER ON THE POST-REVISION X-RAY. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF ANY FURTHER INFORMATION IS PROVIDED, THE COMPLAINT REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    PATIENT FELL OFF BICYCLE, NOW COMPLAINING OF SEVERE PAIN AND INABILITY TO USE ARM. XRAYS AND CT SHOW LOOSE GLENOID COMPONENT. THE ASPIRATION GREW OUT C. ACNES RE-OPERATION WITH COMPONENT CHANGE. PATIENT IS SCHEDULED FOR REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877051 AEQUALIS HUMERAL HEAD 52 MM X 19 MM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS TORNIER S.A.S. DWB252 3916AH 03700386915574

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Hospitalization| R