DJO SURGICAL 343-12-707Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888912172233), received between Mar 9, 2018 and Jul 31, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Unstable” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2026Unstable

  Revision Surgery - due to Instability.

  Patient problems: Joint Laxity

  MAUDE report 50107446 ↗
• InjuryMay 27, 2026Insufficient Device Problem Information

  REVISION SURGERY DUE TO -TRAUMA - POLY INSERT SWAP. UNKNOWN TRAUMA/REVISION REASON.

  Patient problems: Insufficient Information

  MAUDE report 25311152 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - THIS WAS POLY SWAP WAS PERFORMED DUE TO AN EXCISION OF SCAR TISSUE.

  Patient problems: Insufficient Information

  MAUDE report 24554020 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO INFECTION

  Patient problems: Unspecified Infection

  MAUDE report 21393983 ↗
• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY: DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 20872923 ↗
• InjuryDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO FALL LOWER BODY COMPONENT.

  Patient problems: Insufficient Information

  MAUDE report 18406968 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO FRACTURE.

  Patient problems: Limb Fracture

  MAUDE report 16820450 ↗
• InjuryNov 29, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO REMOVAL OF SCAR TISSUE AND LINER EXCHANGE.

  Patient problems: Scar Tissue

  MAUDE report 12882841 ↗
• InjuryAug 25, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10448774 ↗
• InjuryMar 5, 2020Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - PATIENT HAD AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 9794013 ↗
• InjuryJun 27, 2018Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO THE PATIENT HAVING ANTERIOR KNEE PAIN 9 MONTHS POST OPERATIVE FROM INITIAL TOTAL KNEE ARTHROPLASTY WITH DJO COMPONENTS. THE PATIENT ELECTED TO UNDERGO A REVISION TOTAL KNEE ARTHROPLASTY SURGERY. THE SURGEON CHANGED THE POLY FROM A 12MILLIMETER TO 14MILLIMETER AND ADDED A PATELLA AND RESURFACED THE NATIVE PATELLA. THE PATELLA WAS NEVER RESURFACED IN THE ORIGINAL SURGERY. THE FEMUR AND TIBIA STAYED FROM ORIGINAL SURGERY.

  Patient problems: No Code Available; Pain

  MAUDE report 7643509 ↗
• InjuryMar 9, 2018Unstable

  REVISION SURGERY - DUE TO THE PATIENT HAVING INSTABILITY.

  Patient problems: No Code Available

  MAUDE report 7327673 ↗

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