DJO SURGICAL 346-14-705Recalls & reported problems
Encore Medical, L.P. · EMPOWR VVC KNEETM TIBIAL INSERT, SIZE 5, 14MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00190446269960), received between Jun 21, 2019 and Feb 6, 2026 — classified as 12 injuries.
1 other recall cover devices cleared under the same FDA submission (K180930); 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 Available6
Patient problems
- Unspecified Infection8
- Joint Laxity2
- Fall1
- Scar Tissue1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem
InjuryJan 26, 2026Adverse 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
InjurySep 7, 2023Adverse 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
InjuryMay 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 12, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INFECTED KNEE BILATERAL POLY SWAP.
Patient problems: Unspecified Infection
MAUDE report 13743022 ↗InjuryMar 9, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: DUE TO INFECTED KNEE BILATERAL POLY SWAP.
Patient problems: Unspecified Infection
MAUDE report 13713556 ↗InjuryFeb 1, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INFECTION. MODULAR COMPONENT WAS REMOVED AND REPLACED WITH NEW STERILE IMPLANT.
Patient problems: Unspecified Infection
MAUDE report 13418160 ↗InjuryJul 6, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - REMOVAL OF SCAR TISSUE AND INSERT SWAP.
Patient problems: Scar Tissue
MAUDE report 12125461 ↗InjurySep 17, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT SUFFERED A FALL AND DAMAGED THEIR CLOSING WOUND. WASHOUT AND REPLACED THE POLY INSERT.
Patient problems: Fall
MAUDE report 10547478 ↗InjuryJun 21, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INFECTION AND POLY SWAP.
Patient problems: Unspecified Infection
MAUDE report 8722098 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K180930. One submission often covers many models, so check the product and lot details in each record.
- Z-1187-2023 · Dec 22, 2022 · Open, ClassifiedEMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 7, 22MM, REF: 346-22-707; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 8, 22MM, REF: 346-22
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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