DJO SURGICAL 343-10-705Recalls & reported problems
Encore Medical, L.P. · EMPOWR PS KNEETM TIBIAL INSERT, SIZE 5, 10MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00888912171953), received between Feb 7, 2017 and Aug 18, 2026 — classified as 20 injuries.
The most frequently reported specific device problem is “Unstable” (4 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem13
- Unstable4
- Appropriate Device Problem Term/Code Not Available2
- Insufficient Device Problem Information2
- No Apparent Adverse Event2
Patient problems
- Joint Laxity10
- Unspecified Infection5
- Insufficient Information3
- Implant Pain1
- Loss of Range of Motion1
- No Code Available1
- Pain1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
InjuryAug 18, 2026No Apparent Adverse Event
Revision surgery - Due to Unknown Revision reason / Poly swap.
Patient problems: Insufficient Information
MAUDE report 50291513 ↗InjuryJan 19, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT PRESENTED FOR PATELLA RESURFACING AND POLY EXCHANGE. UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 24112142 ↗InjuryJan 7, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryOct 25, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INSTABILITY AND PAIN.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 20530332 ↗InjuryJul 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 23, 2024No Apparent Adverse Event; No Apparent Adverse Event
REVISION SURGERY: DUE TO DOCTOR RESURFACED PT'S PATELLA AND UPSIZED POLY.
Patient problems: Joint Laxity
MAUDE report 19169667 ↗InjuryFeb 27, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 26, 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 COMPLAINED OF INSTABILITY AND PATELLA PAIN.
Patient problems: Joint Laxity; Pain
MAUDE report 15934131 ↗InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - SURGEON FELT PATIENT WAS LOOSE AND INCREASES THICKNESS SIZE IN POLY DURING A POLY SWAP PROCEDURE.
Patient problems: Joint Laxity
MAUDE report 15793784 ↗InjurySep 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 17, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WAS INFECTED. REMOVED THE 5X10 P.S. POLY.
Patient problems: Unspecified Infection
MAUDE report 12333033 ↗InjurySep 16, 2020Insufficient Device Problem Information
REVISION SURGERY - DUE TO UNKNOWN REASONS.
Patient problems: Insufficient Information
MAUDE report 10541485 ↗InjuryJan 13, 2020Adverse Event Without Identified Device or Use Problem
InjuryApr 22, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO A FLEXION CONTRACTURE. POLY WAS REVISED.
Patient problems: Loss of Range of Motion
MAUDE report 8538188 ↗InjuryJan 30, 2019Unstable
REVISION SURGERY - DUE TO PATIENT COMPLAINT OF INSTABILITY. THE SURGEON FELT THAT A THICKER INSERT WOULD CORRECT THIS.
Patient problems: No Code Available
MAUDE report 8290479 ↗InjuryMay 1, 2018Insufficient Device Problem Information
REVISION SURGERY - DUE TO A POSSIBLE INFECTION. THE SURGEON PERFORMED A WASHOUT.
Patient problems: Unspecified Infection
MAUDE report 7476199 ↗InjuryFeb 7, 2017Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT DEVELOPING AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 6308446 ↗
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/METAL/POLYMER devices
- ATTUNE 1506-00-005Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER589 reports
- ATTUNE 1506-00-004Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER580 reports
- JOURNEY 74012812Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER502 reports
- JOURNEY 74011856Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER438 reports
- PERSONA™ 42-5099-094-00Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER406 reports
- JOURNEY 74011857Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER388 reports
- ATTUNE 1506-00-007Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER288 reports
- ATTUNE 1506-00-003Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER271 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page