DJO SURGICAL 353-01-108Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00190446230069), received between Mar 5, 2021 and Jul 24, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Fracture” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO PATIENT WAS COMPLAINING OF PAIN.

  Patient problems: Implant Pain

  MAUDE report 19823569 ↗
• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 19672432 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO CYST BELOW TIBIA IMPLANT.

  Patient problems: Insufficient Information

  MAUDE report 19455661 ↗
• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO PATIENTS STEM SUBSIDED.

  Patient problems: Joint Laxity

  MAUDE report 19282940 ↗
• InjuryMay 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO LOOSENING.

  Patient problems: Joint Laxity

  MAUDE report 16850232 ↗
• InjuryMar 5, 2021Fracture

  REVISION SURGERY - DUE TO PERIPROSTHETIC FRACTURE OF THE PROXIMAL TIBIA.

  Patient problems: Failure of Implant

  MAUDE report 11423587 ↗

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