BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL 46X21X50 HUM HEAD

    MDR report key: 14025425 · Received April 6, 2022

    Report

    Report Number
    0001825034-2022-00842
    Event Type
    Injury
    Date Received
    April 6, 2022
    Date of Event
    May 3, 2022
    Report Date
    August 17, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    UDI-DI
    00880304212237
    PMA / PMN Number
    K193038
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-01884 MEDICAL PRODUCTS: ITEM#: 113952, SM HYBRID GLENOID BASE 4MM; LOT#: 992960 ITEM#: PT-113950, PT HYBRID GLEN POST REGENEREX; LOT#: 964350 ITEM#: 113631, COMP PRIMARY STEM 11MM MINI; LOT#: 65025650 ITEM#: 118001, VERSA-DIAL/COMP TI STD TAPER, LOT#: 465650 COMPONENT CODES: MECHANICAL (G04) - HEAD NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: SIGNIFICANT FINDINGS INCLUDE JOINT INSTABILITY DUE TO THE APPARENT OSTEOLYSIS AND SUSPECTED GLENOID IMPLANT LOOSENING. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE UNRELATED TO THE IMPLANTED ZIMMER BIOMET DEVICE. 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

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL/CORRECTED INFORMATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION FOR AN UNKNOWN REASON ON AN UNKNOWN DAY.. ATTEMPTS HAVE BEEN MADE AND IT WAS REPORTED THAT THE CASE WAS CANCELLED. NO FURTHER INFORMATION IS AVAILABLE FORM THE EVENT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS BEING CONSIDERED FOR A REVISION SURGERY DUE TO FAILURE OF THEIR SUBSCAPULARIS THAT LEAD TO THE PATIENT'S GLENO HUMERAL JOINT UNSTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT SHOULDER SURGERY ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION SURGERY DUE TO A TENDON TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2154280 VERSA-DIAL 46X21X50 HUM HEAD PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES MBF ZIMMER BIOMET, INC. N/A J7089153 00880304212237
    2488497 VERSA-DIAL 46X21X50 HUM HEAD PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES MBF ZIMMER BIOMET, INC. N/A J7089153 00880304212237

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Hospitalization| O| R