Evolution EFSRN5PRRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M684EFSRN5PR1), received between Oct 28, 2020 and Nov 27, 2023 — classified as 4 injuries, 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, SUBCLINICAL NERVE DAMAGE AS POSSIBLE RESULT OF SURGICAL TRAUMA RESULTING IN PAIN OR NUMBNESS OF THE AFFECTED LIMB.

  Patient problems: Pain

  MAUDE report 18208423 ↗
• MalfunctionAug 1, 2023Material Disintegration; Material Disintegration

  ALLEGEDLY, BLACK PARTICLES WERE FOUND ON THE SURFACE OF THE IMPLANT, WHICH CANNOT BE DETECTED WITH THE NAKED EYE. BLACK POWDER PARTICLES CAN BE CLEARLY SEEN WHEN THE IMPLANT COMES INTO CONTACT WITH BONE CEMENT. SO, USER SUSPECTED PRESENCE OF BLACK PARTICLES IN THE IMPLANT AND BONE CEMENT CONTAMINATED BY IMPLANT. BECAUSE OF IMPLANT IS FIXED WITH BONE CEMENT, THE DOCTOR CAN BUT WASH IT WITH WATER AND PUT IT IN PATIENT'S BODY. SIMILAR CASES HAVE HAPPENED THREE TIMES, ONLY THIS CASE WAS RECORDED BY PHOTOS. ACCORDING TO THE STATISTICS, IN THIS HOSPITAL, 150 PRODUCTS (PRODUCT ID:EFSRN5PR) HAS BEEN USED IN OPERATION.

  Patient problems: Insufficient Information

  MAUDE report 17435900 ↗
• InjuryMar 31, 2023Unstable; Appropriate Device Problem Term/Code Not Available; Unstable; Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, PATIENT FELL. LEAD TO INSTABILITY OF THE KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16656320 ↗
• InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR NUMBER: (B)(6). SIDE: R. PRIMARY ASA: P1 - FIT AND HEALTHY. (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 11657248 ↗
• InjuryOct 28, 2020Noise, Audible; Noise, Audible

  ALLEGEDLY, PATIENT IS EXPERIENCING CLICKING AND PAIN WHEN SHE LAYS ON HER SIDE. NO FOLLOW UP WITH HER DOCTOR YET. ADDITIONAL INFORMATION RECEIVED ON 04/22/2020 FROM RELIABILITY ENGINEERING: PRODUCT ID AND LOT INFORMATION. ADDITIONAL INFORMATION RECEIVED ON 10/26/2020 FROM RELIABILITY ENGINEERING: UPDATED PRODUCT ID AND LOT INFORMATION.

  Patient problems: Pain

  MAUDE report 10748493 ↗