DJO SURGICAL 343-13-708Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888912172363), received between Sep 27, 2017 and Jun 5, 2026 — classified as 6 injuries, 1 malfunction.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 25418020 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  DR. PREPPED PATELLA AND REPLACED WITH A LARGER POLY. 69 YR OLD MALE.

  Patient problems: Insufficient Information

  MAUDE report 24693902 ↗
• InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - PATIENT FELL CAUSING INSTABILITY.

  Patient problems: Fall; Joint Laxity

  MAUDE report 18213147 ↗
• InjuryFeb 10, 2022Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY - DUE TO LOOSENING.

  Patient problems: Insufficient Information

  MAUDE report 13506119 ↗
• InjuryNov 7, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY : DUE TO INSTABILITY AFTER A FALL.

  Patient problems: Insufficient Information

  MAUDE report 12759061 ↗
• InjurySep 7, 2021Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY, PATIENT KNEE BECAME LOOSE, NEEDED TO BE REVISED TO A LARGER POLY INSERT.

  Patient problems: Insufficient Information

  MAUDE report 12432813 ↗
• MalfunctionSep 27, 2017Packaging Problem

  COMPLAINT - THERE WAS A SIZE 7X19 IN A 8X13 BOX .

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6899471 ↗

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-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-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-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