DJO SURGICAL 343-10-707Recalls & reported problems
Encore Medical, L.P. · EMPOWR PS KNEETM TIBIAL INSERT, SIZE 7, 10MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Empowr knee insert is a plastic part used in knee replacement surgery. Reports mostly describe follow-up surgery to replace or adjust the implant, often mentioning infection and knee looseness or instability. There are 23 reports naming its identifier, with 23 injuries and no deaths, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00888912171991), received between Dec 22, 2016 and Aug 13, 2026 — classified as 23 injuries.
The most frequently reported specific device problem is “Unstable” (6 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
- Unstable6
- Appropriate Device Problem Term/Code Not Available5
- Insufficient Device Problem Information3
Patient problems
- Unspecified Infection9
- Joint Laxity5
- Insufficient Information4
- No Code Available2
- Fall1
- Implant Pain1
- Medical device site infection1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjuryAug 13, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50230348 ↗InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
InjuryMay 5, 2026Insufficient Device Problem Information
REVISION SURGERY DUE TO POLY SWAP / UNKNOWN REVISION REASON
Patient problems: Insufficient Information
MAUDE report 25088972 ↗InjuryFeb 5, 2026Unstable
InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT TORN THEIR RETINACULA, SURGEON OPTED TO SWAP OUT THE POLY, UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 23012368 ↗InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT DID NOT HAVE A RESURFACING OF THE PATELLA.
Patient problems: Insufficient Information
MAUDE report 22049085 ↗InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT FELL AND OPENED THE WOUND, IRRIGATION & DEBRIDEMENT WITH A POLY SWAP DONE.
Patient problems: Fall
MAUDE report 21270248 ↗InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 7, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJan 17, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryNov 20, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT KNEE BECAME OPEN INFECTION AND HAD DRAINAGE. KNEE WAS WASHED OUT AND A NEW IMPLANT (POLY) WAS IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 15503805 ↗InjuryAug 17, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WAS INFECTED. REMOVED SIZE 7X10 EMPOWR P.S. POLY.
Patient problems: Unspecified Infection
MAUDE report 12333001 ↗InjuryJan 13, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - REVISED FOR A TOTAL KNEE ARTHROPLASTY WASHOUT AND LAXITY EVALUATION.
Patient problems: Insufficient Information
MAUDE report 11163283 ↗InjuryJul 17, 2020Appropriate Device Problem Term/Code Not Available
InjuryJan 10, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY DUE TO INFECTION ON RIGHT SIDE.
Patient problems: Unspecified Infection
MAUDE report 9574662 ↗InjuryJan 30, 2019Unstable; Appropriate Device Problem Term/Code Not Available
InjurySep 1, 2017Insufficient Device Problem Information
REVISION SURGERY - DUE TO A WASH OUT AND POLY EXCHANGE.
Patient problems: No Code Available
MAUDE report 6840421 ↗InjuryJun 5, 2017Insufficient Device Problem Information
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 6613260 ↗InjuryDec 22, 2016Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT HAD AN INFECTION; NOT DUE TO IMPLANTS.
Patient problems: Unspecified Infection
MAUDE report 6199936 ↗
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 + 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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