DJO SURGICAL 340-45-009Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888912116145), received between Dec 9, 2016 and Apr 2, 2019 — classified as 5 injuries.

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

• InjuryApr 2, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8474173 ↗
• InjuryFeb 27, 2019Naturally Worn

  REVISION SURGERY - DUE TO POLY WEAR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8376134 ↗
• InjuryJan 16, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - SURGERY ORIGINALLY SCHEDULED FOR A PATELLA FEMORAL REPLACEMENT BUT SINCE THE SURGEON WAS ALREADY IN THE KNEE, HE WENT AHEAD AND JUST SWAPPED THE POLY OUT WITH A NEW ONE FOR THE UNI THE PATIENT ALREADY HAD.

  Patient problems: No Code Available

  MAUDE report 8254898 ↗
• InjuryDec 21, 2016Insufficient Device Problem Information

  SECOND REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION. (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 6197329 ↗
• InjuryDec 9, 2016Insufficient Device Problem Information

  REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6159169 ↗

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.