DJO SURGICAL 343-10-755Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888912171960), received between Feb 6, 2018 and Apr 29, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.

• InjuryApr 29, 2026Patient Device Interaction Problem

  REVISION SURGERY - DUE TO PATIENT HAD STIFFNESS.

  Patient problems: Loss of Range of Motion

  MAUDE report 25025934 ↗
• InjuryApr 29, 2026Patient Device Interaction Problem

  REVISION SURGERY - DUE TO PATIENTS KNEE WAS TIGHT.

  Patient problems: Loss of Range of Motion

  MAUDE report 25025928 ↗
• InjuryJan 16, 2026Unstable

  REVISION SURGERY - DUE TO INSTABILITY, POLY SWAP.

  Patient problems: Joint Laxity

  MAUDE report 24090868 ↗
• InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO PAIN AND INFECTION.

  Patient problems: Implant Pain; Unspecified Infection

  MAUDE report 16735243 ↗
• InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - PATIENT KNEE WAS UNSTABLE A THICKER POLY WAS PLACED.

  Patient problems: Joint Laxity

  MAUDE report 15670219 ↗
• InjuryAug 10, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - THE PATIENT PRESENTED WITH A 6 DEGREE FLEXION CONTRACTURE AND HER RANGE OF MOTION WAS ONLY ABLE TO GET TO 90 DEGREES IN FLEXION. AFTER MANIPULATION WAS COMPLETED, THE SURGEON DECIDED TO OPEN THE JOINT TO CLEAN OUT SCAR TISSUE AND CHANGE THE POLY IN PROCESS.

  Patient problems: Loss of Range of Motion

  MAUDE report 15202809 ↗
• InjuryApr 1, 2022Unstable

  REVISION SURGERY - DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 13979790 ↗
• InjuryFeb 17, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - PATIENT HAD A SKIN INFECTION. SURGEON OPENED THE CAPSULE UP AND WASHED EVERYTHING OUT. HE TOOK THE ORIGINAL POLY AND PUT NEW ONE IN.

  Patient problems: Skin Infection

  MAUDE report 13548625 ↗
• InjuryDec 23, 2020Adverse Event Without Identified Device or Use Problem

  SECOND REVISION SURGERY - THE PATIENT FELL DOWN AND ALSO HAS AN INFECTION.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 11065219 ↗
• InjuryJul 22, 2020Fracture

  REVISION SURGERY - PATIENT FELL AND CAUSED A DISTAL FEMUR FRACTURE, A FEMORAL PLACED AND NEW INSERT WAS PLACED.

  Patient problems: Fall

  MAUDE report 10307539 ↗
• InjuryMar 16, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - THE PATIENT MIGHT HAVE AN INFECTION. THE LINER WAS EXCHANGED WHILE DOING A WASH OUT OF THE KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 9835284 ↗
• InjuryFeb 6, 2018Insufficient Device Problem Information

  REVISION SURGERY - DUE TO THE PATIENT HAVING POPPING THE KNEE.

  Patient problems: No Code Available

  MAUDE report 7244652 ↗

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.