DJO SURGICAL 343-10-708Recalls & reported problems
Encore Medical, L.P. · EMPOWR PS KNEETM TIBIAL INSERT, SIZE 8, 10MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888912172004), received between Aug 22, 2019 and Aug 19, 2026 — classified as 14 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. 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
- Appropriate Device Problem Term/Code Not Available6
- Adverse Event Without Identified Device or Use Problem5
- Unstable3
- Device Dislodged or Dislocated1
- No Apparent Adverse Event1
- Patient-Device Incompatibility1
- Physical Resistance/Sticking1
Patient problems
- Unspecified Infection5
- Joint Laxity3
- No Information2
- Fall1
- Implant Pain1
- Insufficient Information1
- Joint Dislocation1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjuryAug 19, 2026No Apparent Adverse Event
Revision surgery - Due to poly swap.
Patient problems: Insufficient Information
MAUDE report 50312434 ↗InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem
InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem
InjuryJan 9, 2026Device Dislodged or Dislocated
InjuryNov 11, 2025Unstable; Unstable
InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INFECTION OF THE KNEE JOINT CAUSED BY A FALL.
Patient problems: Fall; Unspecified Infection
MAUDE report 23044771 ↗InjuryMay 28, 2025Unstable; 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 22102168 ↗InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 1, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY PATIENT SHOWED SIGNS OF POSSIBLE INFECTION AND POLY WAS SWAPPED.
Patient problems: Unspecified Infection
MAUDE report 15138547 ↗InjuryMar 21, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY : PATIENT HAD A SKIN INFECTION. SURGEON OPENED THE CAPSULE AND CLEANED OUT THE JOINT SPACE THOROUGHLY. HE SWAPPED THE POLYS OUT.
Patient problems: Unspecified Infection
MAUDE report 13841012 ↗InjuryFeb 3, 2021Patient-Device Incompatibility; Appropriate Device Problem Term/Code Not Available
InjuryJul 29, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INSTABILITY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10337991 ↗InjuryMar 12, 2020Appropriate Device Problem Term/Code Not Available; Physical Resistance/Sticking
REVISION SURGERY - STIFFNESS. REVISED THE RIGHT KNEE AND ALSO A PRIMARY ON THE LEFT KNEE.
Patient problems: No Information
MAUDE report 9825950 ↗InjuryAug 22, 2019Unstable; Appropriate Device Problem Term/Code Not Available
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 · 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-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-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-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
- 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.
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