BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE GLENOSPHERE STANDARD

    MDR report key: 7785156 · Received August 15, 2018

    Report

    Report Number
    0001825034-2018-05106
    Event Type
    Injury
    Date Received
    August 15, 2018
    Date of Event
    September 26, 2016
    Report Date
    January 11, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: FIXED LOCKING SCREW [180550; LOT 084440] QTY: 2, COMP PRIMARY STEM 8MM MINI [PART #113628 LOT # 095780 ]. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES AND X-RAYS PROVIDED. THE HUMERAL COMPONENT HAD SUBSIDED AND ROTATED 180 DEGREES PER X-RAYS. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED HOWEVER, IT IS NOTED THAT THE PATIENT WAS A TOBACCO USER, HAD POOR NUTRITION AND HEALTH ISSUES, WAS NONCOMPLIANT AND HAD MULTIPLE FALLS ON HER LEFT SHOULDER WHICH MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. 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: COMPREHENSIVE HUMERAL TRAY 44 MM X 5 MM, [115375; LOT 070520]; CENTRAL SCREW 6.5 MM 3.5 HEX 30 MM LENGTH, [115396; LOT 492050]; FIXED LOCKING SCREW 4.75 MM 3.5 HEX 30 MM LENGTH, [180553; LOT 642760]; FIXED LOCKING SCREW 4.75 MM 3.5 HEX 35 MM LENGTH, [180554; LOT 135720]; E1 RETENTIVE +3 MM HUMERAL BEARING 44 ¿ 36 MM, [EP-115395; LOT 253370]; COMPREHENSIVE MINI BASEPLATE AND TAPER ADAPTOR 25 MM, [010000589; LOT 082010]; FIXED LOCKING SCREW, [180550; LOT 808750]; FIXED LOCKING SCREW, [180550; LOT 084440]. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 05107, 0001825034 - 2018 - 05163, 0001825034 - 2018 - 05164.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A POSSIBLE CLOSED REDUCTION PROCEDURE OF A REVERSE TOTAL SHOULDER ARTHROPLASTY APPROXIMATELY ONE (1) MONTH POST-OPERATIVELY DUE TO DISLOCATION. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY TWO (2) MONTHS POST-OPERATIVELY DUE TO HUMERAL STEM SUBSIDENCE/MIGRATION. PATIENT ALSO HAD COMMINUTED HUMERAL BONE THAT WAS REMOVED. A LARGER HUMERAL TRAY AND BEARING WERE ALSO IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628586 COMPREHENSIVE REVERSE GLENOSPHERE STANDARD PROSTHESIS, SHOULDER PAO ZIMMER BIOMET, INC. N/A 247930

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R