DJO SURGICAL 342-16-707Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 7R 16MM, 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
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888912167642), received between May 13, 2019 and Oct 15, 2025 — classified as 9 injuries.
The most frequently reported specific device problem is “Unstable” (1 report).
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
- Jul 9, 2025Class IIOpen, Classified
Knee implants contain incorrect labeling (size and/or side incorrect)
Z-2286-2025 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem5
- Appropriate Device Problem Term/Code Not Available3
- Unstable1
Patient problems
- Unspecified Infection4
- Implant Pain2
- Joint Laxity2
- Fall1
- Muscular Rigidity1
- Pain1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryOct 15, 2025Unstable; Unstable
IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY AFTER EXPERIENCING PAIN AND INSTABILITY. THE RIGHT 7 MINUS POROUS BASEPLATE HAD FAILED. SURGEON REVISED THE CONSTRUCT USING A 7 RIGHT MINUS UNIVERSAL BASEPLATE, A 12X65 MM STEM, TWO 7X5 MM AUGMENT BLOCKS (ONE ON THE LATERAL SIDE AND ONE ON THE MEDIAL SIDE), ONE 6X5 MM AUGMENT BLOCK ON THE LATERAL SIDE, AND A 7X16 MM 3D INSERT.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 23286218 ↗InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY: DUE TO PATIENT FELL POST OPERATIVELY CAUSING LOOSENING.
Patient problems: Fall; Joint Laxity
MAUDE report 22155455 ↗InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - POLY SWAP DUE TO PATIENT DISCOMFORT.
Patient problems: Pain
MAUDE report 16061776 ↗InjuryJun 3, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INFECTION ON POLY SWAP ON DATE.
Patient problems: Unspecified Infection
MAUDE report 14598605 ↗InjuryAug 27, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT PRESENTED WITH INFECTION. SURGEON DECIDED TO WASH OUT THE JOINT AND EXCHANGE THE POLY INSERT.
Patient problems: Unspecified Infection
MAUDE report 8937894 ↗InjuryMay 13, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT'S LEG STIFFENING.
Patient problems: Muscular Rigidity
MAUDE report 8605709 ↗
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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