Evolution ETPKN4SRRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI M684ETPKN4SR1), received between Jun 8, 2020 and Sep 18, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2025Unstable; Unstable

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY. SRNJR NUMBER: (B)(6). SIDE: R. GENDER: F.

  Patient problems: Insufficient Information

  MAUDE report 23089992 ↗
• InjuryNov 9, 2023Unstable; Unstable

  ALLEGEDLY, UNSTABLE AND PAINFUL KNEE PROSTHESIS.

  Patient problems: Insufficient Information

  MAUDE report 18107046 ↗
• InjuryAug 3, 2022Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, PATIENT UNDERWENT R TKR ON (B)(6) 2019. REVISED ON (B)(6) 2022 DUE TO ASEPTIC LOOSENING, TIBIA HAD NOT BONDED WITH CEMENT. C1252.

  Patient problems: Failure of Implant

  MAUDE report 15160402 ↗
• InjuryFeb 17, 2022Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, LOOSENING IS RECOGNIZED IN THE TIBIA TRAY, AND THE PATIENT IS AWARE OF THE PAIN. PHYSICIAN'S FINDINGS: NO STICKING OF TIVIA TRAY AND CEMENT. THERE IS A LOT OF CEMENT IN THE BONE, BUT IT DOESN'T FIT THE TIVIA TRAY AT ALL. (B)(6).

  Patient problems: Pain

  MAUDE report 13549592 ↗
• InjuryJul 7, 2021Dull, Blunt; Loss of Osseointegration; Dull, Blunt; Loss of Osseointegration

  ALLEGEDLY, PATIENT UNDERWENT R TKR ON (B)(6) 2021. REVISED ON (B)(6) 2021 DUE TO REPORTED LOOSENING OF THE TIBIA. (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12127582 ↗
• InjuryJun 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  SAE # (B)(4): ALLEGEDLY, THE PATIENT HAD A LUXATION OF THE RIGHT HIP WITH PERIPROSTHETIC FRACTURE. JOINT REDUCTION PERFORMED ON (B)(6) 2017. SAE #(B)(4): ALLEGEDLY, PATIENT SAT ON THE SOFA. WHEN LIFTING THE RIGHT LEG, THE HIP LUXATED. RECOVERED AFTER REMOVING HEAD AND MODULAR NECK OF THE RIGHT HIP. BFARM CASE NUMBER:(B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12070420 ↗
• 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 11657301 ↗
• InjuryMar 10, 2021Unstable; Migration; Unstable; Migration

  ALLEGEDLY, PATIENT UNDERWENT RIGHT TKR ON (B)(6) 2017. BASE PLATE SUBSIDED INTO TIBIA RESULTING IN SIGNIFICANT VALGUS AND INSTABILITY. PATIENT REVISED ON (B)(6) 2021 WITH EVOLUTION REVISION TIBIAL BASE AND STEM EXTENSIONS. LINER REPLACED WITH A 20MM ONE. (B)(6) - (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11457066 ↗
• InjuryJun 8, 2020Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO LOOSENING. (B)(6).

  Patient problems: No Information

  MAUDE report 10129265 ↗