BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL 42X18X46 HUM HEAD

    MDR report key: 8395511 · Received March 6, 2019

    Report

    Report Number
    0001825034-2019-00896
    Event Type
    Injury
    Date Received
    March 6, 2019
    Date of Event
    January 28, 2019
    Report Date
    May 15, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    PMA / PMN Number
    K060716
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. DOB - UNKNOWN MONTH AND DAY IN 1946. REPORTED EVENT WAS CONFIRMED BY REVIEW OF FOLLOW UP VISIT NOTES. AS PER FIRST FOLLOW UP NOTES, THE PATIENT PRESENTED TODAY AFTER HAVING A WOUND DISCHARGE AND DEHISCENCE OF THE UPPER 1 CM OF THE SCAR, WHICH DEVELOPED 1 WEEK BACK AND PATIENT DOES NOT SHOW ANY SIGNS OF INFECTION AROUND THE WOUND, NO TENDERNESS. ON THE SECOND FOLLOW UP THE WOUND STILL HAS A BIT OF DEHISCENCE PROXIMALLY BUT NO LONGER DRAINING AND APPEARS MUCH HEALTHIER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). CONCOMITANT MEDICAL PRODUCTS: 115738 COMPR NANO HMRL PPS 38MM 696790; 118001 VERSA-DIAL/COMP TI STD TAPER 170590; 113954 MD HYBRID GLENOID BASE 4MM 984350; PT-113950 PT HYBRID GLEN POST REGENEREX 066130. REPORT SOURCE- FOREIGN- (B)(6). INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 00895; 0001825034 - 2019 - 00897; 0001825034 - 2019 - 00900.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD INITIAL SHOULDER ARTHROPLASTY, AND SUBSEQUENTLY EXPERIENCED SUPERFICIAL SURGICAL INCISION INFECTION ONE MONTH POST IMPLANTATION. THE PATIENT WAS PRESCRIBED ANTIBIOTICS, AND THE DEHISCENCE WAS NOTED TO BE IMPROVING WITHIN ONE MONTH OF TREATMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188606 VERSA-DIAL 42X18X46 HUM HEAD PROSTHESIS, SHOULDER MBF ZIMMER BIOMET, INC. N/A 769260

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention