Evolution ETPK1578Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M684ETPK15781), received between Jan 30, 2020 and Jan 30, 2020 — classified as 1 injury.

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

• InjuryJan 30, 2020Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, WHILE COMPLETING A SITE INITIATION FOR A CLINICAL STUDY, DR. (B)(6) MENTIONED HE HAD SEEN HIS FIRST ASPECTIC LOOSENING OF OUR BIOFOAM TIBIA PRODUCT IN ONE OF THIS PATIENTS. HE INDICATED HE WOULD COMPLETE A REVISION TOTAL KNEE ARTHROPLASTY ; HOWEVER, IT WAS NOT CLEAR IF THE REVISION SURGERY HAS ALREADY BEEN DONE OR WAS GOING TO BE SCHEDULED. ADDITIONAL INFORMATION RECEIVED ON 01/09/2020 FROM (B)(6): ADDING TIBIAL BASE PRODUCT NUMBER (ETPL-B7SL). CONFIRMATION OF REVISION RECEIVED. ADDITIONAL INFORMATION RECEIVED ON 09/22/2020 FROM (B)(6): ADDING PRODUCT INFORMATION, PATIENT NAME, IMPLANT AND EXPLANT DATE. COMPONENT NOT REVISED: EVOLUTION®MP FEM CS/CR POROUS SIZE 7 PRIMARY LEFT, PRODUCT NUMBER: EFSRP7PL, LOT NUMBER: 1576883.

  Patient problems: No Information

  MAUDE report 9647575 ↗