EVOLUTION EFSRP5PRRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M684EFSRP5PR1), received between Oct 29, 2024 and Oct 29, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Packaging Problem” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2024Packaging Problem; Packaging Problem

  ALLEGEDLY, IN A TKA OPERATION, DIFFERENT SIZES OF IMPLANTS WERE INSERTED. THE FEMUR SIZE 6 NON-POROUS LEFT WAS CONTAINED IN THE FEMUR SIZE 5 PORUS RIGHT. AFTER THE DECISION OF THE SIZE WAS MADE AT THE OPERATION, THE BOX OF THE TARGET IMPLANT WAS DOUBLE-CHECKED BY THE DOCTOR AND THE NURSE, AND THE NURSE OPENED THE BOX AND HANDED IT TO THE DOCTOR, WHO WAS ABOUT TO PLACE THE IMPLANT IN THE PATIENT. THE PATIENT'S FEMUR WAS CEMENTED, ALTHOUGH IT WAS A HYBRID, AND THE OPERATION WAS SUCCESSFULLY COMPLETED WITH NO DAMAGE TO THE PATIENT'S HEALTH. JAPAN (B)(4). PRODUCT INSIDE THE BOX: PRODUCT ID: EFSRN6PL EVOLUTION®MP FEM CS/CR NON-POR/ LOT NO: MP2002559/ QTY: (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20561132 ↗

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