Evolution ETPK1556Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M684ETPK15561), received between Aug 18, 2020 and Jun 10, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  (B)(4) - PATIENT # (B)(6). ALLEGEDLY, PATIENT HAD PRIMARY SURGERY (B)(6) 2021 ON LEFT KNEE. THIS IS A POST OP COMPLAINT ON (B)(6) 2022. PES ANSERINUS BURSITIS/PAIN OF LEFT KNEE. NO REVISION AT THIS POINT, PAIN IS ONGOING/RESOLVED. NO FURTHER DETAILS AVAILABLE.

  Patient problems: Inflammation; Pain

  MAUDE report 19503491 ↗
• 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 14750015 ↗
• InjuryJul 15, 2021Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, PATIENT REVISED DUE TO LOOSENING OF THE TIBIA.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12174911 ↗
• InjuryFeb 3, 2021Break; Break

  ALLEGEDLY, THERE WAS A FRACTURED OF TIBIAL BASE PLATE ON THE RIGHT KNEE. COMPONENTS NOT REVISED: -EVOLUTION FEMORAL EFSRP6PR, LOT# 1750136. -ADVANCE METAL BACK PATELLA KPON35MB, LOT# 1743601.

  Patient problems: Insufficient Information

  MAUDE report 11275671 ↗
• InjuryAug 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  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 10421052 ↗