DJO SURGICAL 346-14-708Recalls & reported problems
Encore Medical, L.P. · EMPOWR VVC KNEETM TIBIAL INSERT, SIZE 8, 14MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00190446218999), received between Feb 28, 2023 and Apr 23, 2026 — classified as 7 injuries.
The most frequently reported specific device problem is “Mechanical Problem” (1 report).
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 Problem5
- Mechanical Problem1
- No Apparent Adverse Event1
- Unstable1
Patient problems
- Insufficient Information2
- Unspecified Infection2
- Joint Laxity1
- Loss of Range of Motion1
- Muscle/Tendon Damage1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO WASH OUT, INSERT EXCHANGE. POSSIBLE INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24974720 ↗InjuryMar 26, 2026Unstable; Adverse Event Without Identified Device or Use Problem
InjuryDec 16, 2025Mechanical Problem; Mechanical Problem
PATIENT'S KNEE WAS TOO TIGHT, DOWNSIZED THE INSERT AND DID SOME SOFT TISSUE RELEASES
Patient problems: Loss of Range of Motion
MAUDE report 23824436 ↗InjuryJun 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO DOCTOR COMPLETED AN I & D AND POLY SWAP.
Patient problems: Insufficient Information
MAUDE report 19495033 ↗InjuryMay 18, 2024No Apparent Adverse Event; No Apparent Adverse Event
InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PT UNDERWENT A SYNOVECTOMY AND POLY SWAP.
Patient problems: Insufficient Information
MAUDE report 18522858 ↗InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THIS WAS A POLY SWAP ON A PATIENT THAT FELL AND PARTIALLY RUPTURED QUAD TENDON.
Patient problems: Muscle/Tendon Damage
MAUDE report 16456457 ↗
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/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.
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