BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL/COMP TI STD TAPER

    MDR report key: 15310376 · Received August 29, 2022

    Report

    Report Number
    0001825034-2022-01974
    Event Type
    Injury
    Date Received
    August 29, 2022
    Date of Event
    August 6, 2020
    Report Date
    September 21, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    UDI-DI
    00880304217249
    PMA / PMN Number
    K193038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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: 0001825034-2022-01970; 0001825034-2022-01971; 0001825034-2022-01972; 0001825034-2022-01973. CONCOMITANT MEDICAL PRODUCTS: ITEM#: PT-113950, PT HYBRID GLEN POST REGENEREX; LOT#: 607920; ITEM#: 113952, SM HYBRID GLENOID BASE 4MM; LOT#: 165380; ITEM#: 113611, COMP PRIMARY STEM 11MM MICRO, LOT#: 821310; ITEM#: 113032, VERSA-DIAL 42X18X46 HUM HEAD; LOT#: 306460. DEVICE EVALUATED BY MFR: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. 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. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; G3; G6; H1; H2 UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS PRODUCT WAS NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAD REVISION SURGERY APPROXIMATELY ONE YEAR AND EIGHT MONTHS AFTER THE INITIAL SURGERY DUE TO PAIN, LOSS OF RANGE OF MOTION, AND LOOSENING 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
    2101807 VERSA-DIAL/COMP TI STD TAPER SHOULDER PROSTHESIS, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED / EXTREMITIES MBF ZIMMER BIOMET, INC. 118001 926330 00880304217249

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H