BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL 42X18X46 HUM HEAD

    MDR report key: 15959386 · Received December 12, 2022

    Report

    Report Number
    0001825034-2022-02748
    Event Type
    Injury
    Date Received
    December 12, 2022
    Date of Event
    November 29, 2022
    Report Date
    March 30, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    UDI-DI
    00880304212206
    PMA / PMN Number
    K060716
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM#118001 ; LOT#139970, ITEM# 113610; LOT#115800, ITEM#20-8075-004-01; LOT#63178536, ITEM#00-4326-040-46; LOT#62700439. DEVICE REMAINS IMPLANTED. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-02747, 0001825034-2022-02745.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. ASSOCIATED PRODUCTS AND REPORTS 0001822565-2022-03533 ITEM# 00-4326-040-46; LOT# 62700439. 0001822565-2022-03555 ITEM# 20-8075-004-01; LOT# 63178536. 0001825034-2022-02745-1 ITEM# 113610; LOT# 115800. 0001825034-2022-02747-1 ITEM# 118001; LOT# 139970.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PROPOSED CODE: MECHANICAL (G04)- HEAD. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. MEDICAL RECORDS ASSESSED AND TIMELINE CREATED. REVIEW OF MEDICAL RECORDS AND MMI WERE ASSESSED. IT IS NOTED THAT THE REVIEW IS FOR A LINKED COMPLAINT GLENOID FRACTURE AND ARE NOT CORRESPONDING TO THIS COMPLAINT. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. ASSOCIATED PRODUCTS AND REPORTS ------------------------------------------- 0001825034-2022-02745-2 ITEM#113610; LOT#115800 0001825034-2022-02747-2 ITEM#118001; LOT#139970 0001822565-2022-03533-1 ITEM00432604046; LOT#62700439 0001825034-2023-00191-1 ITEM#113610; LOT#115800.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IS TO UNDERGO A REVISION SIX(6) YEARS POST IMPLANTATION DUE DISASSOCIATION AND PAIN. HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SIX (6) YEARS POST IMPLANTATION DUE DISASSOCIATION AND PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT HAD INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY APPROXIMATELY SEVEN YEARS AGO. SUBSEQUENTLY, THE PATIENT, UNDERWENT STAGE ONE OF A TWO STAGE REVISION DUE TO PAIN AND A LARGE, NON-CONTAINED, GLENOID DEFECT. DURING THE SURGERY, THE GLENOID WAS FOUND FRAGMENTING AND A SYNOVECTOMY WAS PERFORMED DUE TO SYNOVITIS. ALL COMPONENTS WERE REMOVED, AND A NON-ZIMMER BIOMET SPACER WAS PLACED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386101 VERSA-DIAL 42X18X46 HUM HEAD PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED MBF ZIMMER BIOMET, INC. NI 214780 00880304212206

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Other| H| R SEE NARRATIVE IN H10.