BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP AUG MINI BSPLT W TPR SM

    MDR report key: 16474082 · Received March 2, 2023

    Report

    Report Number
    0001825034-2023-00422
    Event Type
    Injury
    Date Received
    March 2, 2023
    Date of Event
    February 5, 2023
    Report Date
    August 7, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304993235
    PMA / PMN Number
    K172502
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PRODUCT CODE - (B)(4). 110031402 - HUMERAL TRAY - 64437435. 110031424 - HUMERAL BEARING - 64833589. 115310 - GLENOSPHERE - 290790. 180551 - SCREW - 294290. 180553 - SCREW - 380950. 180553 - SCREW - 006800. 180550 - SCREW - 758340. 115395 - CENTRAL SCREW - 071640. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-00421

    Additional Manufacturer Narrative · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. H10: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS AND RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: OFFICE VISIT: PRESENTS WITH PAIN, SPECIFICALLY IN THE ANTERIOR REGION OF THE SHOULDER. THE PATIENT REPORTS SLEEPING IN HER RECLINER WHEN SHE FELT THE PAIN APPROXIMATELY 2 MONTHS PRIOR. X-RAYS SHOW DISSOCIATION OF THE GLENOSPHERE FROM THE BASEPLATE WITH NO APPARENT LOOSENING OF THE HUMERAL COMPONENT OR BASEPLATE. SCAPULAR NOTCHING IS PRESENT WITH MULTIPLE LOOSE BODIES AROUND THE JOINT. PLAN FOR REVISION. REVISION, HEMIARTHROPLASTY: REVISION DUE TO DISLOCATION AND DISASSOCIATION OF THE GLENOID COMPONENTS. SEVERE METALLOSIS NOTED THROUGHOUT THE JOINT. SEVERE WEAR OF THE INFERIOR ASPECT OF THE POLY AS WELL AS SOME WEAR OF THE METAL OF THE HUMERAL TRAY. HUMERAL STEM FOUND STABLE. EROSION OF THE CORTICAL BONE AT THE LESSER TUBEROSITY WITH STEM VISIBLE THROUGH A CORTICAL WINDOW. SEVERE WEAR OF THE BASEPLATE NOTED WITH THE CENTRAL SCREW HOLE ALSO MALFORMED. ¿THERE HAD BEEN MELTING OF THE POSTERIOR ASPECT OF THE BASEPLATE AND THEN IT HAD REACHED ANNEALED WITH METAL COVERING THE POSTERIOR LOCKING SCREW IN THE BASEPLATE. THIS MADE THAT SCREW INACCESSIBLE.¿ ¿BETWEEN THE PATIENT¿S PRE-EXISTING GLENOID BONE DEFORMITY AS WELL AS THE BONE LOSS WITH REMOVAL OF THE FAILED BASEPLATE, THERE WAS NOT ENOUGH REMAINING NATIVE GLENOID BONE TO PERFORM A REVERSE SHOULDER ARTHROPLASTY EVEN WITH A LARGE AUGMENT.¿ HEMI COMPONENTS PLACED WITHOUT COMPLICATION. THE PATIENT TO REMAIN NON-WEIGHT BEARING WITH NO SHOULDER MOTION FOR 4 WEEKS THEN PROCEED WITH ROM EXERCISES. X-RAYS: REVERSE TOTAL SHOULDER ARTHROPLASTY OF THE RIGHT SHOULDER WITH IMPLANT DISASSEMBLY OF THE GLENOSPHERE, NOW LOCATED ALONG THE LATERAL ASPECT OF THE HUMERAL COMPONENT. BONY REMODELING OF THE DISTAL CLAVICLE AND AC JOINT, ACROMION WITH EXTENSIVE CURVILINEAR CALCIFICATION OF THE JOINT CAPSULAR WHICH PRESUMABLY RELATES TO PATIENT'S KNOWN HISTORY OF METALLOSIS. OSTEOPENIA IS PRESENT. CENTRAL SCREW HOME AFFIRMATION CANNOT BE CONFIRMED ON X-RAY. TAPER ADAPTER NOT CLEARLY SEEN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY. APPROXIMATELY 1 MONTH POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO PAIN, SCAPULAR NOTCHING, AND DISSOCIATION OF THE GLENOSPHERE FROM THE BASEPLATE AS NOTED ON X-RAY. DURING THE REVISION, SEVERE METALLOSIS WAS NOTED THROUGHOUT THE JOINT DUE TO SEVERE WEAR OF THE POLY AND BASEPLATE AS WELL AS THE DISLOCATION AND DISASSOCIATION. SIGNIFICANT BONE LOSS AND EROSION WERE ALSO NOTED. THE STEM WAS LEFT INTACT, AND THE GLENOID WAS CONVERTED TO A HEMIARTHROPLASTY WITH A NEW HEAD AND TAPER PLACED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2001316 COMP AUG MINI BSPLT W TPR SM PROSTHESIS, SHOULDER PHX ZIMMER BIOMET, INC. N/A 64394791 00880304993235

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R SEE H10 NARRATIVE.