Depuy Synthes Evo4K220 (UDI 00817613020987)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00817613020987), received between Jun 1, 2021 and Nov 11, 2021 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (8 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING A KNEE ARTHROSCOPY SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE IMAGE MANAGEMENT SYSTEM- EVOLUTION 4K DEVICE HAD A GREEN BAR ON THE SCREEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12797859 ↗
• MalfunctionNov 11, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING A KNEE ARTHROSCOPY SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE IMAGE MANAGEMENT SYSTEM- EVOLUTION 4K DEVICE HAD A GREEN BAR ON THE SCREEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12797716 ↗
• MalfunctionNov 4, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING A DEMONSTRATION, IT WAS OBSERVED THAT THE IMAGE MANAGEMENT SYSTEM- EVOLUTION 4K DEVICE DID NOT DISPLAY IMAGE IN THE LIVE VIDEO AFTER IT WAS CONNECTED TO THE GENERATOR. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12752759 ↗
• MalfunctionNov 4, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING A DEMONSTRATION, IT WAS OBSERVED THAT THE IMAGE MANAGEMENT SYSTEM- EVOLUTION 4K DEVICE DID NOT DISPLAY IMAGE IN THE LIVE VIDEO AFTER IT WAS CONNECTED TO THE GENERATOR. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12752737 ↗
• MalfunctionNov 3, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT BEFORE AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE IMAGE MANAGEMENT SYSTEM- EVOLUTION 4K DEVICE WAS NOT ABLE TO TAKE THE VIDEO. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745307 ↗
• MalfunctionOct 27, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING A DEMONSTRATION, IT WAS OBSERVED THAT THE IMAGE MANAGEMENT SYSTEM- EVOLUTION 4K DEVICE COULD NOT DISPLAY AN IMAGE IN THE LIVE VIDEO MENU AFTER THE CAMERA WAS CONNECTED TO THE GENERATOR. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12706518 ↗
• MalfunctionOct 25, 2021Computer Software Problem; Display or Visual Feedback Problem; Computer Software Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE IMAGE MANAGEMENT SYSTEM DEVICE HAD SOFTWARE ISSUE; AND THAT THERE WAS NO PICTURE SIGNAL. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. SOFTWARE ISSUE. NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12691833 ↗
• MalfunctionJun 1, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE SCREEN ON THE IMAGE MANAGEMENT SYSTEM EVOLUTION 4K DEVICE WENT DARK TWICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11914854 ↗