DJO SURGICAL 340-37-009Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888912115957), received between Jan 8, 2018 and Oct 29, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Naturally Worn” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K020741); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2021Naturally Worn

  REVISION SURGERY - THE INSERT WAS REMOVED AND SWAPPED BECAUSE THE PATIENT HAD SIGNIFICANT WEAR ON THE PREVIOUSLY IMPLANTED INSERT, ON THE POSTERIOR END. REPLACED WITH ONLAY TIBIA INSERT EPIK SZ 37X11MM.

  Patient problems: Insufficient Information

  MAUDE report 12721763 ↗
• InjurySep 13, 2018Naturally Worn

  REVISION SURGERY - DUE TO THE PATIENT HAVING EXTREME POLY WEAR.

  Patient problems: No Code Available

  MAUDE report 7874773 ↗
• InjuryJan 8, 2018Torn Material

  REVISION SURGERY - DUE TO THE PATIENT HAVING A TORN ANTERIOR CRUCIATE LIGAMENT (ACL). THE SURGEON PERFORMED AN ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION AND SWAPPED OUT THE POLY INSERT.

  Patient problems: Failure of Implant

  MAUDE report 7171636 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K020741. One submission often covers many models, so check the product and lot details in each record.

• Z-0010-2008 · Aug 9, 2007 · Terminated
  EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
• Z-0009-2008 · Aug 9, 2007 · Terminated
  EPIK KNEE SYSTEM Angled Insert Impactor LM/RL; Catalog #801-03-051 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.