DJO SURGICAL 341-14-709Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 9L 14MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888912167062), received between Apr 23, 2021 and Jun 23, 2026 — classified as 11 injuries.
The most frequently reported specific device problem is “Unstable” (1 report).
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 Problem7
- Appropriate Device Problem Term/Code Not Available4
- Unstable1
Patient problems
- Unspecified Infection6
- Fall3
- Joint Laxity2
- Pain2
- Diarrhea1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem
InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 6, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT FELL DURING PHYSICAL THERAPY AND HAS SUBSEQUENT PAIN AND INSTABILITY. SURGEON INCREASED THE THICKNESS OF THE POLY.
Patient problems: Fall; Joint Laxity; Pain
MAUDE report 16015389 ↗InjuryAug 8, 2022Adverse Event Without Identified Device or Use Problem
InjuryJul 5, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT INDICATED SOME PAIN IN THE KNEE. THE SURGEON DECIDED TO REVISE AND ADD IN A PATELLA COMPONENT AND ALSO WENT DOWN A POLY SIZE FROM A 14MM TO A 12MM.
Patient problems: Pain
MAUDE report 14921100 ↗InjuryMar 29, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INFECTION AND DRAINAGE FROM KNEE. POLY EXCHANGE.
Patient problems: Unspecified Infection
MAUDE report 13942538 ↗InjuryJun 15, 2021Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT FELL AND BUSTED OPEN HIS INCISION SITE DOWN TO THE IMPLANTS. ALL IMPLANTS ARE INTACT. NO CURRENT INFECTION, BUT IRRIGATING WOUND AND SWAPPING OUT INSERT TO PREVENT INFECTION FROM ESTABLISHING.
Patient problems: Fall
MAUDE report 12005669 ↗InjuryJun 14, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - REVISION OF LEFT TOTAL KNEE ARTHROPLASTY. PATIENT FELL YESTERDAY (DUE TO DIARRHEA), WHEN HE FELL, HE BUSTED OPEN HIS INCISION SITE DOWN TO THE IMPLANTS. ALL IMPLANTS ARE INTACT! NO CURRENT INFECTION, BUT IRRIGATING WOUND AND SWAPPING OUT INSERT TO PREVENT INFECTION FROM ESTABLISHING.
Patient problems: Diarrhea; Fall
MAUDE report 11996822 ↗InjuryApr 23, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO POLY SWAP BECAUSE OF A POSSIBLE INFECTION.
Patient problems: Unspecified Infection
MAUDE report 11713071 ↗
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 341-10-711Encore Medical, L.P. · Guide, Surgical, Instrument1 recall16 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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