DJO SURGICAL 342-14-705Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 5R 14MM, 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
- 14
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888912167529), received between Mar 16, 2018 and Mar 30, 2026 — classified as 14 injuries.
The most frequently reported specific device problem is “Unstable” (3 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
- Jan 5, 2026Class IIOpen, Classified
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
Z-1233-2026 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem11
- Unstable3
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- Joint Laxity6
- Unspecified Infection6
- Fall1
- Loss of Range of Motion1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjuryMar 30, 2026Unstable; Adverse Event Without Identified Device or Use Problem
KNEE WAS UNSTABLE, NEEDED TO INCREASE POLY THICKNESS. FEMALE 71YRS.
Patient problems: Joint Laxity
MAUDE report 24721053 ↗InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO KNEE BECAME TIGHT IN EXTENSION POST-OP.
Patient problems: Loss of Range of Motion
MAUDE report 19103051 ↗InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 25, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THIS CASE WAS A WASH OUT. THE PATIENT UNDERWENT PRIMARY SURGERY THE PRIOR DAY. LATER THE PATIENT DAMAGED HER SUTURE SITE. THUS, SURGEON DID A WASHOUT AND OPTED TO SWAP THE POLY WHILE IN THE JOINT.
Patient problems: Joint Laxity
MAUDE report 15988892 ↗InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT HAD LAXITY IN BOTH FLUXION AND EXTENSION. SURGEON INCREASED THE THICKNESS OF THE POLY.
Patient problems: Joint Laxity
MAUDE report 15581226 ↗InjuryDec 16, 2021Unstable
InjuryJun 25, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD ACUTE INFECTION. PERFORMED AN IRRIGATION AND DEBRIDMENT WITH INSERT EXCHANGE.
Patient problems: Unspecified Infection
MAUDE report 12069212 ↗InjuryDec 18, 2020Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - INFECTED KNEE POLY EXCHANGE.
Patient problems: Unspecified Infection
MAUDE report 11037233 ↗InjuryApr 18, 2019Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE SURGEON SUSPECTING AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 8528808 ↗InjuryMar 16, 2018Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 7345928 ↗
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 · 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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