Evolution ETPKN5SRRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M684ETPKN5SR1), received between Oct 28, 2020 and Nov 23, 2023 — 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.

• InjuryNov 23, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, SUBCLINICAL NERVE DAMAGE AS POSSIBLE RESULT OF SURGICAL TRAUMA RESULTING IN PAIN OR NUMBNESS OF THE AFFECTED LIMB.

  Patient problems: Pain

  MAUDE report 18199441 ↗
• InjuryMar 31, 2023Unstable; Appropriate Device Problem Term/Code Not Available; Unstable; Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, PATIENT FELL, LEADING TO INSTABILITY OF THE KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16656728 ↗
• InjuryMay 11, 2022Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, PATIENT WAS REVISED DUE TO STIFFNESS. COMPONENT NOT REVISED: PRODUCT: ADVANCE ONLAY ALL POLY PATELLA 35MM TRIPEG PRODUCTID: KPONTP35 LOT#:1804141, QTY:1, REVISION NJR NUMBER: (B)(4), SIDE: R, PRIMARY ASA: P1 - FIT AND HEALTHY.

  Patient problems: Loss of Range of Motion

  MAUDE report 14361031 ↗
• InjuryMay 25, 2021Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, PATIENT UNDERWENT R TKR ON (B)(6) 2020. PATIENT SUFFERED PAIN, STIFFNESS AND TIGHTNESS IN FLEXION. THE KEEL SHIFTED POSTERIORLY AND THERE WAS LUCENCY ANTERIORLY. REVISED ON (B)(6) 2021. (B)(6).

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 11880357 ↗
• InjuryOct 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT IS EXPERIENCING CLICKING AND PAIN WHEN SHE LAYS ON HER SIDE. NO FOLLOW UP WITH HER DOCTOR YET. ADDITIONAL INFORMATION RECEIVED ON 04/22/2020 FROM RELIABILITY ENGINEERING: PRODUCT ID AND LOT INFORMATION. ADDITIONAL INFORMATION RECEIVED ON 10/26/2020 FROM RELIABILITY ENGINEERING: UPDATED PRODUCT ID AND LOT INFORMATION.

  Patient problems: Pain

  MAUDE report 10748572 ↗