DJO SURGICAL 343-12-706Recalls & reported problems
Encore Medical, L.P. · EMPOWR PS KNEETM TIBIAL INSERT, SIZE 6, 12MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00888912172226), received between Sep 22, 2017 and Apr 8, 2026 — classified as 18 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 Problem12
- Appropriate Device Problem Term/Code Not Available4
- Unstable4
- Device Operates Differently Than Expected1
Patient problems
- Unspecified Infection6
- Joint Laxity3
- Medical device site infection2
- No Known Impact Or Consequence To Patient2
- Arthralgia1
- Failure of Implant1
- Fall1
- Insufficient Information1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
InjuryApr 8, 2026Unstable; Adverse Event Without Identified Device or Use Problem
InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DUE TO INSTABILITY PATIENT REQUIRED REVISION SURGERY.
Patient problems: Joint Laxity
MAUDE report 23069683 ↗InjuryOct 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 31, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY, POST OPERATIVE INFECTION, IRRIGATION & DRAINAGE.
Patient problems: Medical device site infection
MAUDE report 16052246 ↗InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT HAD HEMATOMA, AND POSSIBLE INFECTION.
Patient problems: Medical device site infection
MAUDE report 16015377 ↗InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT FELL AND HAD QUAD INJURY. REPAIRED TENDON AND DID POLY EXCHANGE.
Patient problems: Fall
MAUDE report 15626585 ↗InjuryOct 21, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INSTABILITY.
Patient problems: Insufficient Information
MAUDE report 12678260 ↗InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT INFECTED, REPLACED EMPOWR-P.S. POLY. SIZE 6X12MM.
Patient problems: Unspecified Infection
MAUDE report 12088878 ↗InjuryOct 14, 2020Unstable
InjuryMay 12, 2020Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT HAVING AN INFECTION. PERFORMED A WASH OUT AND POLY EXCHANGE.
Patient problems: Unspecified Infection
MAUDE report 10048911 ↗InjuryApr 9, 2020Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT PRESENTED WITH INFECTION OF HER TOTAL KNEE REPLACEMENT.
Patient problems: Unspecified Infection
MAUDE report 9943674 ↗InjuryApr 8, 2020Unstable; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT WAS UNSTABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9938740 ↗InjurySep 26, 2019Appropriate Device Problem Term/Code Not Available
InjuryMay 14, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO A POLY EXCHANGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8608694 ↗InjurySep 22, 2017Device Operates Differently Than Expected
REVISION SURGERY - DUE TO THE PATELLA HAVING TRACKING ISSUES.
Patient problems: No Code Available
MAUDE report 6888301 ↗
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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