BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE COBALT CHROME +5 HUMERAL TRAY

    MDR report key: 7785175 · Received August 15, 2018

    Report

    Report Number
    0001825034-2018-05163
    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
    KWS
    PMA / PMN Number
    PK113069
    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). UPON RECEIPT OF INFORMATION RECEIVED AND REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON RECEIPT OF INFORMATION RECEIVED AND REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCTS: VERSA-DIAL GLENOSPHERE STANDARD 36 MM [115310; LOT 247930]; 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 - 05106 , 0001825034 - 2018 - 05107 , 0001825034 - 2018 - 05164 NOT RETURNED TO MANUFACTURER.

    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
    628735 COMPREHENSIVE REVERSE COBALT CHROME +5 HUMERAL TRAY PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 070520

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R