DJO SURGICAL 243-01-105Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00190446231264), received between May 29, 2020 and Nov 7, 2025 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO LOOSENING TIBIA / FEMUR.

  Patient problems: Joint Laxity

  MAUDE report 23504041 ↗
• InjuryOct 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD THE PRIMARY KNEE REPLACEMENT BUT FELT PAIN FROM THE SURGERY. THERE WAS NO CLEAR REASON FOR THE PAIN FROM LOOKING AT THE X-RAY SO SURGEON HAD TO REMOVE IMPLANT DURING A REVISION KNEE.

  Patient problems: Pain

  MAUDE report 23333903 ↗
• InjuryDec 6, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY REQUIRED DUE TO PATIENT FALL AND DISLOCATION/FRACTURE.

  Patient problems: Bone Fracture(s); Fall; Joint Dislocation

  MAUDE report 20861104 ↗
• InjuryMar 28, 2024No Apparent Adverse Event; No Apparent Adverse Event

  REVISION SURGERY - DUE TO POSTERIOR LAXITY. NEEDED TO BE CONVERTED TO PS REVISION WITH STEM.

  Patient problems: Insufficient Information

  MAUDE report 18992525 ↗
• InjuryMay 29, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - FEMUR BECAME LOOSE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10101659 ↗

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