DJO SURGICAL 343-10-709Recalls & reported problems
Encore Medical, L.P. · EMPOWR PS KNEETM TIBIAL INSERT, SIZE 9, 10MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00888912172011), received between Aug 23, 2017 and Apr 23, 2025 — classified as 19 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
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 Problem11
- Appropriate Device Problem Term/Code Not Available6
- Insufficient Device Problem Information1
- Packaging Problem1
Patient problems
- Unspecified Infection7
- Joint Laxity3
- Medical device site infection2
- No Known Impact Or Consequence To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Fall1
- Implant Pain1
- Insufficient Information1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT REPORTED TO THE DOCTOR A WEEK AFTER HIS INITIAL TKA THAT THE PATIENT FELL & SPLIT OPEN HIS WOUND REGARDING THE TKA PREVIOUSLY DONE. DOCTOR WANTED TO EXCHANGE THE POLY EVEN THOUGH THERE WAS NO DAMAGE TO THE INITIAL IMPLANT.
Patient problems: Insufficient Information
MAUDE report 20488373 ↗InjuryJun 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INSTABILITY AND PAIN.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 18044501 ↗InjuryJul 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Medical device site infection
MAUDE report 15820693 ↗InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT WAS EXPERIENCING LATERAL SWELLING AND HIS KNEE DRAINED MULTIPLE TIMES. FINALLY THE SURGEON DECIDED TO OPEN THE JOINT TO CHECK FOR INFECTION. WASHED OUT THE KNEE AND REPLACED THE POLY.
Patient problems: Medical device site infection
MAUDE report 15498024 ↗InjuryAug 19, 2022Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT SHOWED SIGNS OF POSSIBLE INFECTION AND POLY WAS SWAPPED.
Patient problems: Unspecified Infection
MAUDE report 15261764 ↗InjuryJun 28, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 14843280 ↗InjuryMay 11, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 14364716 ↗InjurySep 29, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT KNEE WAS WASHED, NEW POLY WAS IMPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12547523 ↗InjuryDec 11, 2020Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - REVISED DUE TO INFECTION. POLY EXCHANGED.
Patient problems: Unspecified Infection
MAUDE report 10994290 ↗InjuryJul 14, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - TO ADD A PATELLA.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10271359 ↗InjuryApr 11, 2019Packaging Problem
InjuryJan 3, 2019Insufficient Device Problem Information
REVISION SURGERY - DUE TO PAIN IN KNEE; POSSIBLE INFECTION.
Patient problems: No Code Available; Pain
MAUDE report 8214736 ↗InjuryOct 8, 2018Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT FALLING AND RUPTURING THEIR QUADRICEPS TENDON. THE SURGEON CHANGED THE INSERT.
Patient problems: Fall; Rupture
MAUDE report 7944812 ↗InjuryAug 23, 2017Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO AM IMPLANT SWAP TO CLEAN OUT THE KNEE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6813588 ↗
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.
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