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DJO SURGICAL 353-03-109Recalls & reported problems

Encore Medical, L.P. · DJO EMPOWR KNEETM, PRESS FIT BP MINUS, 9L · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00190446230274), received between Apr 15, 2021 and May 2, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Insufficient Device Problem Information1

Patient problems

  • Implant Pain1
  • Insufficient Information1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY - DUE TO PAIN.

    Patient problems: Implant Pain

    MAUDE report 16856736 ↗
  • InjuryApr 15, 2021Insufficient Device Problem Information

    REVISION SURGERY - DUE TO DR. REVISED THE LEFT TOTAL KNEE BECAUSE THE PATIENT WAS COMPLAINING.

    Patient problems: Insufficient Information

    MAUDE report 11672083 ↗

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

Other PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page