DJO SURGICAL 353-04-105Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00190446230335), received between Mar 3, 2021 and Jun 14, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 14, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - PATIENT HAD TIBIAL FAILURE. REVISION SURGERY OF TIBIAL COMPONENT ONLY. REMOVED POLY & TIBIA & REPLACED WITH UNIVERSAL TIBIA & STEM.

  Patient problems: Insufficient Information

  MAUDE report 14690300 ↗
• InjuryNov 1, 2021Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY - DUE TO TIBIAL SUBSIDENCE.

  Patient problems: Joint Laxity

  MAUDE report 12733922 ↗
• InjuryMar 3, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - THE PATIENT FELL, AFTER A RECENT SURGERY. TIBIA WENT INTO VARUS. REVISED THE PRESS FIT TIBIA WITH A UNIVERSAL TIBIA, CEMENTED STEM, AND THICKER POLY.

  Patient problems: Fall

  MAUDE report 11404567 ↗

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