BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR PROLONG 40MM BRNG +3 RET

    MDR report key: 13497673 · Received February 9, 2022

    Report

    Report Number
    0001822565-2022-00373
    Event Type
    Injury
    Date Received
    February 9, 2022
    Date of Event
    January 14, 2022
    Report Date
    March 30, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00887868231444
    PMA / PMN Number
    K181611
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2022-00372, 0001822565-2022-00374. CONCOMITANT MEDICAL PRODUCTS: ITEM#: 110030776, GLENOSPHERE STANDARD OFFSET 40 MM DIAMETER; LOT#: 65087566. ITEM#: 110031400, MINI TRAY +5MM COCR +0 OFFSET; ITEM#: 65171060. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS REQUESTED BUT NOT RETURNED BY HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2022-00372, 0001822565-2022-00374. CONCOMITANT MEDICAL PRODUCTS: ITEM#: 110030776, GLENOSPHERE STANDARD OFFSET 40 MM DIAMETER; LOT#: 65087566. ITEM#: 110031400, MINI TRAY +5MM COCR +0 OFFSET; ITEM#: 65171060. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS REQUESTED BUT NOT RETURNED BY HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2022-00372-1. 0001822565-2022-00374-1. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; G3; G6; H1; H2. UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THE PRODUCT SHOULD NOT HAVE BEEN REPORTED. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER NUMBER 0001822565-2022-00928.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY NINE (9) WEEKS LATER DUE TO DISASSOCIATION OF THE IMPLANTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY NINE (9) WEEKS LATER DUE TO DISASSOCIATION OF THE IMPLANTS.

    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
    920599 CR PROLONG 40MM BRNG +3 RET SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES KWS ZIMMER BIOMET, INC. N/A 64653557 00887868231444

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Male Hospitalization| R SEE H10 NARRATIVE