BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER CENTRAL SCREW

    MDR report key: 8866377 · Received August 6, 2019

    Report

    Report Number
    0001825034-2019-03463
    Event Type
    Injury
    Date Received
    August 6, 2019
    Date of Event
    July 17, 2019
    Report Date
    November 27, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K132239
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI: (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THERE IS IMPLANT DISASSEMBLY DESCRIBED ON THE REVIEWER ASSESSMENT FORM, RESULTING IN MALALIGNMENT OF THE GLENOSPHERE WITH THE BASE PLATE. THE MALALIGNED GLENOSPHERE DOES APPROPRIATELY ARTICULATE WITH THE HUMERUS COMPONENT. THERE IS EVIDENCE OF MALFUNCTION. VARIOUS CONTRIBUTING FACTORS COULD RESULT IN THIS PROBLEM, ONE OF WHICH COULD BE CENTRAL SCREW LOOSENING; HOWEVER THIS CANNOT BE CONFIRMED ON THE PROVIDED IMAGES. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: COMP RVRS 25MM BSPLT HA+ADPTR, CAT: 010000589, LOT: 637360; COMP RVS CNTRL 6.5X25MM ST/RST, CAT: 115395, LOT: 536570; COMP RVRS SHLDR GLNSP STD 36MM, CAT: 115310, LOT: 386590; COMP NLK SCR 3.5HEX 4.75X30 ST, CAT: 180560 LOT: 702390; COMP NLK SCR 3.5HEX 4.75X25 ST, CAT: 180559, LOT: 252970; COMP NLK SCR 3.5HEX 4.75X15 ST, CAT: 180557, LOT: 860880; COMP RVS TRAY CO 44MM, CAT: 115370, LOT: 471880; COMP PRIMARY STEM 13MM MINI, CAT: 113633, LOT: 732980; ARCOM XL 44-36 STD HMRL BRNG ,CAT: XL-115363, LOT: 756020. REPORT SOURCE - FOREIGN - (B)(6). PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    THE SURGEON IMPLANTED A COMPLETE COMPREHENSIVE REVERSE SHOULDER; HOWEVER, ON COMPLETING A ROUTINE POST OPERATIVE X-RAY ONE DAY POST-OPERATIVELY, THE GLENOSPHERE APPEARED TO HAVE DETACHED FROM THE COMPREHENSIVE MINI BASEPLATE. THE SURGEON FOUND THAT THE GLENOSPHERE HAD DETACHED FROM THE BASEPLATE AND REMOVED IT. THE SURGEON THEN REMOVED THE HUMERAL TRAY AND BEARING TO GAIN ACCESS TO THE GLENOID MINI BASEPLATE. IT WAS FOUND THAT THE CENTRAL SCREW WAS NOT FULLY SEATED, AS SUCH, THE SURGEON TIGHTENED THE CENTRAL SCREW AND RECHECKED IT¿S POSITION USING THE DRILL GUIDE. THE CENTRAL SCREW WAS FOUND TO BE FULLY SEATED AT THIS POINT AND THEN SURGEON REPLACED THE GLENOSPHERE, HUMERAL TRAY AND BEARING FROM NEW STOCK. THE SURGEON EXPRESSED SATISFACTION THAT THE PROBABLE CAUSE FOR THE GLENOSPHERE DETACHMENT WAS THE CENTRAL SCREW NOT BEING FULLY SEATED DURING THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657942 COMPREHENSIVE REVERSE SHOULDER CENTRAL SCREW PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. 536570

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R