BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL/COMP TI STD TAPER

    MDR report key: 6904726 · Received September 29, 2017

    Report

    Report Number
    0001825034-2017-07590
    Event Type
    Injury
    Date Received
    September 29, 2017
    Date of Event
    August 25, 2017
    Report Date
    December 28, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    PMA / PMN Number
    PK060716
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 115310, COMP RVRS SHLDR GLNSP STD 36MM, 593670. 115330, BIOMOD/COMP REV BASE STD, 436740. 118001, VERSA-DIAL/COMP TI STD TAPER, 297700. 11-113706, BIO-MOD ST.10X115 W/ALIGN HOLE, 936090. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 07589. 0001825034 - 2017 - 07591. 0001825034 - 2017 - 07592.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IT IS UNKNOWN WHETHER THE LOT # FOR THIS ITEM IS 297720 OR 297700. CONCOMITANT MEDICAL PRODUCTS: 115381, COMP RVS CNTRL SCR 6.5X25MM, ST 319780; 180501, COMP LOCKING SCREW 4.75X20MM, 436110; 180501, COMP LOCKING SCREW 4.75X20MM, 436140; 180502, COMP LOCKING SCREW 4.75X25MM, 788750; XL-115363, ARCOM XL 44-36 STD HMRL BRNG, 520600. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS AND PROVIDED OP NOTES. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. X-RAYS RIGHT SHOULDER AP, AXILLARY AND SCAPULAR VIEWS COMPREHENSIVE RIGHT REVERSE SHOULDER ARTHROPLASTY WITH DISASSOCIATED GLENOSPHERE WHICH HAS MIGRATED ANTERIORLY AND CRANIALLY, AND IS TILTED SUPERIORLY. SCAPULAR NOTCHING IS PRESENT ALONG WITH HETEROTOPIC OSSIFICATION VERSUS FRACTURE DEFORMITY OF THE INFERIOR GLENOID RIM. OP NOTES REMOVAL OF ASEPTICALLY LOOSE REVERSED RIGHT TOTAL SHOULDER ARTHROPLASTY. THE SCARRED ANTERIOR SHOULDER CAPSULE WAS INCISED AND EXTENSIVE METALLOSIS WAS ENCOUNTERED. RADIOGRAPHS SHOWED SEVERE OSTEOPENIA. THE POLY CUP AND METAL TRAY WERE REMOVED FROM THE MORSE TAPER ON THE STEM, EXPOSING GLENOID. THE GLENOSPHERE WAS GROSSLY LOOSE AND HAD SEPARATED FROM THE BASEPLATE, WHICH WAS GROSSLY LOOSE. NO SCREWS HAD ANY FIXATION AND THE BASEPLATE AND SCREWS WERE REMOVED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT SHOULDER REVISION APPROXIMATELY SIX YEARS POST-IMPLANTATION DUE TO PAIN, DYSFUNCTION, ASEPTIC LOOSENING, ELEVATED METAL ION LEVELS, AND ADVERSE LOCAL TISSUE REACTION. DURING THE REVISION, THE GLENOSPHERE AND BASEPLATE WERE FOUND TO BE LOOSE. EXTENSIVE WEAR ON TRUNNION WAS NOTED, WHICH IS SUSPECTED TO BE THE SOURCE OF THE METALLOSIS AND METAL ION ELEVATION. ALL COMPONENTS WERE REVISED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT SHOULDER REVISION APPROXIMATELY EIGHT YEARS POST-IMPLANTATION DUE TO PAIN, DYSFUNCTION, ASEPTIC LOOSENING, ELEVATED METAL ION LEVELS, AND ADVERSE LOCAL TISSUE REACTION. DURING THE REVISION, THE GLENOSPHERE AND BASEPLATE WERE FOUND TO BE LOOSE. EXTENSIVE WEAR ON TRUNNION WAS NOTED, WHICH IS SUSPECTED TO BE THE SOURCE OF THE METALLOSIS AND METAL ION ELEVATION. ALL COMPONENTS WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684975 VERSA-DIAL/COMP TI STD TAPER PROSTHESIS, SHOULDER MBF ZIMMER BIOMET, INC. N/A 297720

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R