DJO SURGICAL 343-10-710Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888912172028), received between Jul 20, 2018 and Jun 7, 2025 — classified as 13 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJun 7, 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 22163107 ↗
• InjuryJul 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - HEMATOMA.

  Patient problems: Hematoma

  MAUDE report 17284320 ↗
• InjuryDec 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - PATIENT SHOWED SIGNS OF INFECTION AND AN IRRIGATION & DRAINAGE AND POLY SWAP WAS PERFORMED.

  Patient problems: Medical device site infection

  MAUDE report 16061773 ↗
• InjuryJul 7, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO AN INFECTION, IRRIGATION AND DRAINAGE POLY SWAP.

  Patient problems: Unspecified Infection

  MAUDE report 14951966 ↗
• InjuryMay 26, 2021Insufficient Device Problem Information

  REVISION SURGERY - UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 11890667 ↗
• InjuryOct 14, 2020Unstable

  REVISION SURGERY - DUE TO INSTABILITY.

  Patient problems: No Code Available

  MAUDE report 10680486 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10580169 ↗
• InjuryApr 24, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO POSSIBLE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 9995744 ↗
• InjuryApr 11, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO UNKNOWN REASONS.

  Patient problems: No Information

  MAUDE report 9951630 ↗
• InjuryJan 30, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY DUE TO PATIENT FALLING AND OPENED UP THE INCISION.

  Patient problems: Fall

  MAUDE report 9648051 ↗
• InjurySep 13, 2019Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY - PATELLA WAS SUBLUXING.

  Patient problems: Failure of Implant

  MAUDE report 9050336 ↗
• InjuryFeb 28, 2019Insufficient Device Problem Information

  REVISION SURGERY - DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8379620 ↗
• InjuryJul 20, 2018Insufficient Device Problem Information

  SECOND REVISION SURGERY - WE WERE NOTIFIED BY THE SURGEON ON (B)(6) 2018, THAT HIS PATIENT THAT HE HAD PERFORMED AN IRRIGATION AND DRAINAGE (I&D) AND POLY SWAP ON FROM MONDAY, NEEDED TO HAVE AN ADDITIONAL IRRIGATION AND DRAINAGE (I&D) WASHOUT AND POLY SWAP.

  Patient problems: No Code Available

  MAUDE report 7708127 ↗

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.