DJO SURGICAL 341-10-711Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 11L 10MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00888912166881), received between Feb 21, 2018 and Aug 19, 2026 — classified as 16 injuries.
The most frequently reported specific device problem is “Unstable” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Jun 2, 2025Class IIOpen, Classified
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.
Z-2125-2025 · Root cause: Packaging change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem11
- Appropriate Device Problem Term/Code Not Available2
- Unstable2
- Device Slipped1
- No Apparent Adverse Event1
Patient problems
- Unspecified Infection7
- Insufficient Information3
- Joint Laxity2
- Medical device site infection2
- Adhesion(s)1
- Fall1
- Loss of Range of Motion1
- No Code Available1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
InjuryAug 19, 2026No Apparent Adverse Event
Revision surgery - Due to unknown revision reason / Poly Swap.
Patient problems: Insufficient Information
MAUDE report 50334414 ↗InjuryAug 7, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50175927 ↗InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO PATIENT WAS FOUND TO HAVE AN INFECTION IN THE JOINT. DOCTOR DECIDED TO DO AN I&D ALONG WITH A POLY SWAP.
Patient problems: Unspecified Infection
MAUDE report 24918864 ↗InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY: RESURFACED PATELLA AND UPSIZED POLY THICKNESS, UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 23045396 ↗InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT FELL AND RUPTURED INCISION AFTER PRIMARY. DID A WASHOUT AND POLY SWAP.
Patient problems: Fall; Unspecified Infection
MAUDE report 22181166 ↗InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 19, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT FELL AND NEEDED A GASTROC FLAP SURGERY. EXCHANGED THE POLY FOR A NEW ONE.
Patient problems: Insufficient Information
MAUDE report 18754781 ↗InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Medical device site infection
MAUDE report 15455933 ↗InjuryAug 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Medical device site infection
MAUDE report 15315054 ↗InjuryApr 25, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO STIFFNESS. LYSIS OF ADHESIONS.
Patient problems: Adhesion(s); Loss of Range of Motion
MAUDE report 14193278 ↗InjuryFeb 3, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: THE PATIENT HAD AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 9660949 ↗InjuryFeb 21, 2018Device Slipped
REVISION SURGERY - DUE TO THE PATIENT EXPERIENCING LAXITY, THE LIGAMENT TENSION WAS LOOSE. SURGEON ADDED A THICKER POLY.
Patient problems: No Code Available
MAUDE report 7286260 ↗
Other Guide, Surgical, Instrument devices
- NA 03.037.017Synthes GmbH · Guide, surgical, instrument346 reports
- EVOS 71174934Smith & Nephew, Inc. · Guide, surgical, instrument149 reports
- LCP 323.042Synthes GmbH · Guide, surgical, instrument129 reports
- DJO SURGICAL 342-10-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall51 reports
- DJO SURGICAL 341-10-707Encore Medical, L.P. · Guide, Surgical, Instrument81 reports
- NA 03.010.404Synthes GmbH · Guide, surgical, instrument73 reports
- DJO SURGICAL 341-14-708Encore Medical, L.P. · Guide, Surgical, Instrument1 recall22 reports
- DJO SURGICAL 342-14-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall14 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 · each recall links to the FDA recall notice
- 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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