DJO SURGICAL 343-10-706Recalls & reported problems
Encore Medical, L.P. · EMPOWR PS KNEETM TIBIAL INSERT, SIZE 6, 10MM · Class 2 · Implant
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00888912171984), received between Sep 6, 2018 and Jun 29, 2026 — classified as 21 injuries.
The most frequently reported specific device problem is “Unstable” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem10
- Appropriate Device Problem Term/Code Not Available7
- Unstable3
- Loose or Intermittent Connection2
- Detachment of Device or Device Component1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Unspecified Infection5
- Joint Laxity4
- Insufficient Information3
- Fall2
- Medical device site infection2
- Pain2
- Failure of Implant1
- Foreign Body In Patient1
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
InjuryJun 29, 2026Unstable
InjuryMar 11, 2026Unstable; Detachment of Device or Device Component
REVISION SURGERY - INSTABILITY, BROKEN FRAGMENTED PIECES LEFT IN PATIENT.
Patient problems: Foreign Body In Patient; Joint Laxity
MAUDE report 24574077 ↗InjuryDec 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT WOUND IS NOT HEALING WASH AND CHANGED THE POLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18229382 ↗InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT KNEE GOT INFECTED DID A POLY SWAP.
Patient problems: Medical device site infection
MAUDE report 15934126 ↗InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT HAS GOUT AND SURGEON SUSPECTED AN INFECTION. HE PLANNED TO PERFORM AND IRRIGATION & DRAINAGE AND DECIDED TO CHANGE THE TIBIAL POLY INSERT INTRA-OPERATIVE.
Patient problems: Medical device site infection
MAUDE report 15840370 ↗InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT FELL, AND OPENED UP AS STITCHES.
Patient problems: Fall
MAUDE report 15643084 ↗InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT WAS HAVING PATELLA PAIN. RESURFACED PATELLA AND SWAPPED POLY DURING SURGERY. LARGER POLY WAS USED TO GAIN MORE STABILITY AS WELL.
Patient problems: Pain
MAUDE report 15642916 ↗InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 5, 2022Appropriate Device Problem Term/Code Not Available
InjuryFeb 16, 2022Unstable
REVISION SURGERY - DUE TO INSTABILITY.
Patient problems: Insufficient Information
MAUDE report 13542101 ↗InjuryNov 22, 2021Appropriate Device Problem Term/Code Not Available
InjuryAug 18, 2021Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - DUE TO LOOSE KNEE.
Patient problems: Insufficient Information
MAUDE report 12338594 ↗InjuryMar 29, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - CLEAN OUT AND POLY SWAP. PATIENT PRESENTED LOOSE.
Patient problems: Failure of Implant
MAUDE report 11582596 ↗InjuryJan 13, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD LAXITY IN TOTAL KNEE ARTHROPLASTY.
Patient problems: Insufficient Information
MAUDE report 11163274 ↗InjurySep 11, 2020Adverse Event Without Identified Device or Use Problem
InjuryJul 17, 2020Appropriate Device Problem Term/Code Not Available
InjuryDec 10, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO POLY EXCHANGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9444554 ↗InjuryNov 6, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WAS INFECTION POLY SWAP.
Patient problems: Unspecified Infection
MAUDE report 9285999 ↗InjurySep 6, 2018Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT FALLING AND CREATING AN OPEN WOUND. THE WOUND WAS CLEANED OUT AND A (PS) POSTERIOR STABILIZED INSERT WAS CHANGED.
Patient problems: Fall; Wound Dehiscence
MAUDE report 7853256 ↗
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 · TerminatedEMPOWR 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 · TerminatedEMPOWR 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 · TerminatedEmpowr 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 · TerminatedEmpowr 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 · TerminatedEmpowr 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
Other Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive devices
- iTotal® PS TPS111111102Conformis, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive327 reports
- ATTUNE 1506-00-006Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive287 reports
- ATTUNE 1506-00-008Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive233 reports
- iTotal® Cruciate Retaining (CR) Knee Replacement System TCR121111102Conformis, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive150 reports
- ATTUNE 1506-70-007Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 recall2 deaths74 reports
- ATTUNE 1516-40-506Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive121 reports
- ATTUNE 1516-40-605Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive120 reports
- ATTUNE 1506-70-006Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 recall70 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.