DJO SURGICAL 353-01-105Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00190446230038), received between Apr 14, 2020 and Jul 27, 2026 — classified as 3 injuries.

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

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

• InjuryJul 27, 2026Unstable

  Revision surgery due to Loosening.

  Patient problems: Joint Laxity

  MAUDE report 50011310 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  REVISION SURGERY - DUE TO THE PATIENT FELL AND HER TIBIA SUBSIDED APPROXIMATELY 8MM.

  Patient problems: Joint Laxity

  MAUDE report 23482482 ↗
• InjuryApr 14, 2020Unstable

  REVISION SURGERY - REVISED LEFT TOTAL KNEE FOR PAIN AND POSSIBLE LOOSE/SUBSIDED TIBIAL COMPONENT. IT WAS DETERMINED THAT THE TIBIAL COMPONENT WAS NOT LOOSE BUT IT APPEARED TO HAVE POSSIBLY SUBSIDED INTO THE TIBIA ON THE ANTERIOR AND MEDIAL EDGES.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9957991 ↗

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