DJO SURGICAL 343-11-708Recalls & reported problems
Encore Medical, L.P. · EMPOWR PS KNEETM TIBIAL INSERT, SIZE 8, 11MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888912172127), received between Feb 19, 2019 and Jun 1, 2026 — classified as 11 injuries.
The most frequently reported specific device problem is “Unstable” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem6
- Appropriate Device Problem Term/Code Not Available2
- Unstable2
- No Apparent Adverse Event1
Patient problems
- Unspecified Infection4
- Joint Laxity2
- Failure of Implant1
- Implant Pain1
- Insufficient Information1
- Joint Impingement1
- No Code Available1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THIS SURGERY WAS PERFORMED BECAUSE SURGEON WAS DOING A QUAD TENDON REPAIR AND WANTED TO EXCHANGE THE POLY AND PATELLA, UNKNOWN REASON.
Patient problems: Joint Impingement
MAUDE report 25355612 ↗InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 10, 2024No Apparent Adverse Event; No Apparent Adverse Event
InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 26, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INSTABILITY.
Patient problems: Insufficient Information
MAUDE report 15104448 ↗InjuryMay 20, 2022Unstable
REVISION SURGERY - DUE TO INSTABILITY. WENT FROM 11 PS TO A 14 VVC INSERT.
Patient problems: Failure of Implant
MAUDE report 14463032 ↗InjuryJan 11, 2021Appropriate Device Problem Term/Code Not Available
InjuryFeb 19, 2019Unstable
REVISION SURGERY - DUE TO THE PATIENT AND THE SURGEON DECIDING TO EXCHANGE THE 11 MILLIMETER POLY INSERT FOR A THICKER 14 MILLIMETER INSERT IN ORDER TO INCREASE STABILITY IN THE PATIENT'S PRIMARY POSTERIOR STABILIZED KNEE.
Patient problems: No Code Available
MAUDE report 8350822 ↗
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-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 + 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 1506-70-006Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 recall70 reports
- ATTUNE 1516-40-605Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive120 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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