EVOLUTION EFSRP6PLRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M684EFSRP6PL1), received between Nov 2, 2021 and Jun 20, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryJun 20, 2022Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, 7 MONTHS POST OP HAD INCREASED WEIGHT BEARING PAIN. 44 MONTHS POST OP- NO COMPLAINT JUST VISIT TO DOCTOR BUT CAN SEE SOME LOOSENING ON (B)(6) 2022 PATIENT WAS IN PAIN, HYPERFLEX OCCURRED IN SHOW DUE TO OTHER ISSUES COMPONENTS HAVE NOT BEEN REVISED. THIS WAS A PROPHECY CASE(B)(4).

  Patient problems: Pain

  MAUDE report 14750066 ↗
• InjuryNov 2, 2021Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, REVISED FOR BROKEN LOOSE TIBIA AND FEMUR EASILY REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 12738752 ↗

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