DJO SURGICAL 343-14-755Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888912172448), received between Jun 15, 2020 and Sep 28, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2023Unstable; 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 17840669 ↗
• InjuryAug 25, 2021Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - PATIENT HAD AN ANTIBIOTIC SPACER PUT IN ABOUT A MONTH AGO FOR INFECTION, WHICH CONSISTED OF A PS FEMUR AND PS INSERT. SPACER WAS REMOVED AND REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 12365535 ↗
• InjuryJun 15, 2020Fracture; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - SURGEON WAS REPAIRING A PATELLA FRACTURE WHEN HE CALLED AGENT FROM THE OPERATING ROOM TO BRING IN A VVC INSERT TO REPLACE THE PS INSERT THAT WAS IMPLANTED BY SURGEON. AGENT DO NOT HAVE THE ITEM NUMBER THAT WAS REMOVED AS HE WAS NOT IN THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10153311 ↗

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-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
• 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.