DJO SURGICAL 347-08-706Recalls & reported problems
Encore Medical, L.P. · EMPOWR PARTIAL KNEETM, Tibial Insert, Size 6, 8mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00190446294917), received between Jan 13, 2021 and Apr 26, 2022 — classified as 3 injuries.
The most frequently reported specific device problem is “Fitting Problem” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K191325); 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Fitting Problem1
Patient problems
- Unspecified Infection2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INFECTED KNEE. POLY WAS REMOVED FOR IRRIGATION AND DRAINAGE, REPLACED WITH NEW INSERT.
Patient problems: Unspecified Infection
MAUDE report 14208920 ↗InjuryDec 28, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 13096048 ↗InjuryJan 13, 2021Fitting Problem
COMPLAINT/PRIMARY SURGERY - SURGEON WENT TO PUT IN THE INSERT BUT IT WASN'T SEATED COMPLETELY IN THE BASEPLATE. HOSPITAL DISCARDED A MORE DETAILED DESCRIPTION FROM AGENT: SURGEON WAS ATTEMPTING TO IMPACT THE FINAL POLY IMPLANT INTO THE TIBIAL BASEPLATE BUT COULDN'T GET THE ANTERIOR ASPECT TO FULLY SEAT/LOCK. IT WAS GOOD ON THE POSTERIOR SIDE. SURGEON PULLED OUT ANOTHER POLY WHICH SEATED/LOCKED FINE.
Patient problems: Insufficient Information
MAUDE report 11163271 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K191325. One submission often covers many models, so check the product and lot details in each record.
- Z-0480-2021 · Jun 19, 2020 · Open, ClassifiedEMPOWR Partial Knee Peg Drill; Model: 800-06-008.
- Z-0479-2021 · Jun 19, 2020 · Open, ClassifiedEMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007.
Other PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices
- LinkSymphoKnee 880-307/21WALDEMAR LINK GmbH & Co. KG · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls2 reports
- Scorpio 73-3710Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls1 report
- Scorpio 73-3110Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls0 reports
- Arthrex® AR-503-TTTEArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall14 reports
- Arthrex® AR-503-TTTJArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall9 reports
- ENGAGE 1-10011-300Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- Arthrex® AR-503-TTTGArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- ENGAGE 1-10003-400Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall6 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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