BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL/COMP TI STD TAPER

    MDR report key: 13087664 · Received December 27, 2021

    Report

    Report Number
    0001825034-2021-03419
    Event Type
    Injury
    Date Received
    December 27, 2021
    Date of Event
    November 30, 2021
    Report Date
    February 10, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    UDI-DI
    00880304217249
    PMA / PMN Number
    K193038
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: 0001825034-2021-03417, 0001825034-2021-03418. CONCOMITANT MEDICAL PRODUCTS: ITEM# 113954; LOT# 996800. ITEM# PT-113950; LOT# 241890. ITEM# 115330; LOT# 734280. ITEM# 405889; LOT# 321360. ITEM# 405883; LOT# 291840. ITEM# 405800; LOT# 579190. ITEM# 115395; LOT# 346230. ITEM# 180554; LOT# 705840. ITEM# 180550; LOT# 464210. ITEM# 180552; LOT# 697300. ITEM# 180550; LOT# 787440. ITEM# 118001; LOT# 386740. ITEM# 115310; LOT# 244620. ITEM# 110031424; LOT# 64980771. ITEM# 110031399; LOT# 65142051. ITEM# 110004347; LOT# 770440. ITEM# 113042; LOT# 594640. ITEM# 115736; LOT# 866520R. ITEM# 20-8000-000-11; LOT# 63706262. REPORT SOURCE: FOREIGN - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS REQUESTED BUT NOT RETURNED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. TAPER ADAPTER IS NOT RELATED TO GLENOID LOOSENING, THEREFORE THE DEVICE WAS NOT INVOLVED IN THE REPORTED EVENT. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY FOUR (4) YEARS AND ONE (1) MONTH POST-IMPLANTATION DUE TO ROTATOR CUFF FAILURE AND LOOSE GLENOID COMPONENT. SURGEON STATED THAT AT THE TIME OF THE PRIMARY IMPLANTATION, THE PATIENT HAD UNDIAGNOSED INFLAMMATORY ARTHROPATHY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    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
    1987218 VERSA-DIAL/COMP TI STD TAPER PROSTHESIS, EXTREMITIES MBF ZIMMER BIOMET, INC. NI 256620 00880304217249

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Hospitalization| R SEE NARRATIVE IN H10