BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STEM EXTREMITIES IMPL

    MDR report key: 11601589 · Received April 1, 2021

    Report

    Report Number
    0009613350-2021-00157
    Event Type
    Injury
    Date Received
    April 1, 2021
    Date of Event
    March 24, 2021
    Report Date
    December 24, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    PHX
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT INCLUDES DATA RELATED TO THE INTRAOPERATIVE COMPLICATION ONLY. THEREFORE THIS MDR IS OBSOLETE. PLEASE INVALIDATE THE CASE FROM YOUR SYSTEM. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 0

    D10: MEDICAL PRODUCTS: ANATOMICAL SHOULDER, HUMERAL STEM, CEMENTED, 12, 100 MM; CATOLOG#: 01.04211.123; LOT#: 3015699; ANATOMICAL SHOULDER REVERSE, HUMERAL CUP, 0, RETRO; CATALOG #: 01.04223.100; LOT#: 3032165; UNK CUP EXTREMITIES IMPL WIN GEN; CATALOG #: UNKNOWN; LOT#: UNKNOWN; TM REVERSE 36MM GLENOSPHERE; CATALOG #: 00-4349-036-11; LOT#: 64463135; TM RVS BASE PLT 15MM POST +0; CATALOG #: 00-4349-015-00; LOT#: 64612803. THERAPY DATE: (B)(6) 2021. THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE PREVIOUS MEDWATCH. ADDITIONAL INFORMATION WAS RECEIVED ON APR 21, 2021. THE MANUFACTURER RECEIVED OTHER SOURCE DOCUMENTS FOR REVIEW. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    SEE H10.

    Description of Event or Problem · 0

    PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT A REVISION SURGERY DUE TO LOOSENING AND MIGRATION OF GLENOID AND FRACTURE OF THE BASEPLATE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: UNKNOWN GLENOID EXTREMITIES IMPL WIN GEN; ITEM# UNKNOWN; LOT# UNKNOWN, UNKNOWN BASEPLATE EXTREMITIES IMPL WIN GEN; ITEM# UNKNOWN; LOT# UNKNOWN, UNKNOWN CUP EXTREMITIES IMPL WIN GEN; ITEM# UNKNOWN; LOT# UNKNOWN. THERAPY DATE: (B)(6) 2021. THE MANUFACTURER DID NOT RECEIVE X-RAYS FOR REVIEW. OTHER SOURCE DOCUMENTS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON RIGHT SIDE AND WAS REVISED DUE TO LOOSENING/MIGRATION OF GLENOID AND FRACTURE OF BASEPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497958 UNKNOWN STEM EXTREMITIES IMPL EXTREMITY PROSTHESIS PHX ZIMMER SWITZERLAND MANUFACTURING GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R