EVOLUTION EFSAN5PRRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M684EFSAN5PR1), received between Nov 4, 2022 and Apr 17, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PT WAS IN PAIN, COULD NOT STAND OR WALK ON THE PRODUCT. PATIENT BELIEVES SHE HAS NERVE AND LIGAMENT DAMAGE.

  Patient problems: Loss of Range of Motion; Nerve Damage; Pain

  MAUDE report 19126960 ↗
• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, REPORTER BECAME AWARE OF SOME NITRX COMPLAINTS FROM A SURGEON IN IDAHO HOWEVER, NO INFORMATION ABOUT THE COMPLAINTS WERE GIVEN TO REPORTER. MICROPORT ORTHOPEDICS VP R&D PROD. DEVELOPMENT STATED THAT HE RECEIVED A PHONE CALL FROM MIKE SHATZER(SALES REP) SAYING THAT A DOC IN IDAHO HAD A FEW PATIENTS COME BACK IN WITH PAINFUL, SWOLLEN KNEES. HE CONTACTED THE REP TO SEE IF HE COULD GET MORE DETAILS. HE ASKED A SERIES OF QUESTIONS THAT HE DID NOT KNOW THE ANSWER. NO PART/LOT NUMBERS ARE GIVEN AND IT HAS NOT BEEN INDICATED HOW MANY EVENTS/PATIENTS HAVE OCCURRED REGARDING THESE ISSUES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022: A TOTAL OF 8 COMPLAINTS WERE RECEIVED WITH ALL RELEVANT INFORMATION INCLUDED IN EACH INCIDENT FORM. THE 7 REMAINING COMPLAINTS ARE CAPTURED UNDER DIFFERENT MICROPORT INCIDENT GROUP NUMBERS. ALLEGEDLY, RECURRING KNEE EFFUSION. NO INFECTION TO DATE. IT WAS CONFIRMED THAT EACH OF THESE PATIENTS WERE SEEN FOR FOLLOW-UP APPOINTMENTS TO ADDRESS INFLAMMATION IN THEIR KNEES. THE SURGEON CONFIRMED THAT NONE OF THE PATIENTS HAD INFECTIONS AND THAT THEIR KNEES HAD FLUID BUILDUP THAT WAS DRAINED. THE SURGEON HAS NOT BEEN ABLE TO DETERMINE IF THESE EVENTS WERE C

  Patient problems: Fluid Discharge; Inflammation; Pain

  MAUDE report 15729847 ↗