DJO SURGICAL 353-01-109Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00190446230076), received between Mar 23, 2018 and Jan 9, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K171991); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2026Patient Device Interaction Problem

  REVISION SURGERY - DUE TO SUBSIDENCE.

  Patient problems: Joint Laxity

  MAUDE report 24031323 ↗
• InjuryNov 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - PATIENT'S TIBIAL COMPONENT FROM PRIMARY SURGERY COLLAPSED REQUIRING A REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18204840 ↗
• InjuryApr 3, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - SURGEON REVISED THE INSERT AND TIBIAL COMPONENT BECAUSE IT SUBSIDED. HE CEMENTED THE UNIVERSAL TIBIA WITH 10MMS OF AUGMENTS ON BOTH SIDES OF THE TIBIA AND USED A STEM.

  Patient problems: No Information

  MAUDE report 9921015 ↗
• InjuryMar 23, 2018Loose or Intermittent Connection

  COMPLAINT - DURING A 4 MONTH FOLLOW-UP WITH AN EMPOWR POROUS KNEE PATIENT, THE SURGEON NOTICED THAT THE "FEMUS" WAS LOOSE. THE PATIENT IS ALSO BEING WORKED UP FOR AN INFECTION. THE SURGEON INDICATED THE LABS WILL BE "WORKED UP" THE NEXT DAY.

  Patient problems: Unspecified Infection

  MAUDE report 7366390 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171991. One submission often covers many models, so check the product and lot details in each record.

• Z-0508-2024 · Nov 10, 2023 · Open, Classified
  DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108
• Z-0258-2024 · Sep 29, 2023 · Open, Classified
  DJO EMPOWR Knee Punch Handle, REF: 801-05-040
• Z-0060-2021 · Aug 3, 2020 · Open, Classified
  DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for EMPOWR Porous Knee - Product Usage: The Tibial Punch Handle is used in conj