EVOLUTION EFSRP5PLRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M684EFSRP5PL1), received between Aug 18, 2020 and Aug 18, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

1 other recall cover devices cleared under the same FDA submission (K140735); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ALLEGEDLY, PATIENT WAS REVISED DUE TO FEMORAL COMPONENT OVERSIZED, AND THE PATIENT MOTION WAS QUITE LIMITED, WITH A RANGE OF 0 TO 30 DEGREES, WITH A HARD STOP AT 30 DEGREES.

  Patient problems: Loss of Range of Motion

  MAUDE report 10420831 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140735. One submission often covers many models, so check the product and lot details in each record.

• Z-0699-2025 · Oct 29, 2024 · Open, Classified
  EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE 6 LEFT PRIMARY, REF: EFSRN6PL Knee prosthes