DJO SURGICAL 242-02-107Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888912171878), received between Dec 10, 2019 and Feb 17, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (K160342); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2026Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY - DUE TO LOOSENING.

  Patient problems: Joint Laxity

  MAUDE report 24373551 ↗
• InjuryNov 24, 2025Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY - DUE TO ASEPTIC LOOSENING

  Patient problems: Aseptic loosening

  MAUDE report 23640729 ↗
• InjuryNov 10, 2025Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY - DUE TO ASEPTIC LOOSENING.

  Patient problems: Aseptic loosening

  MAUDE report 23519079 ↗
• InjuryJun 19, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY: DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 22290583 ↗
• InjuryMay 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT - DUE TO SWELLING AND INSTABILITY WAS OCCURRING FOR THE LAST FEW MONTHS.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 19347905 ↗
• InjuryMay 10, 2024Adverse 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 19294270 ↗
• InjuryJul 28, 2021Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY - THE TOTAL KNEE FAILED DUE TO THE FEMUR BECAME LOOSE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12239528 ↗
• InjuryDec 10, 2019Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - SURGEON NOTICED FEMORAL COMPONENT LOOSENING, AND DECIDED THE BEST COURSE OF ACTION WAS TO REMOVE ALL COMPONENTS, AND REPLACE WITH FOUNDATION REVISION IMPLANTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9444580 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160342. One submission often covers many models, so check the product and lot details in each record.

• Z-0041-2018 · Sep 15, 2017 · Terminated
  EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene
• Z-0042-2018 · Sep 15, 2017 · Terminated
  EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHM
• Z-1139-2017 · Jan 10, 2017 · Terminated
  Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to m
• Z-0325-2017 · Sep 19, 2016 · Terminated
  Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.
• Z-0766-2017 · Sep 19, 2016 · Terminated
  Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabilized implant