DJO SURGICAL 353-01-106Recalls & reported problems
Encore Medical, L.P. · DJO EMPOWR KNEETM, PRESS FIT BP, 6L · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00190446230045), received between Nov 21, 2019 and Sep 24, 2026 — classified as 7 injuries.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K171991); 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Appropriate Device Problem Term/Code Not Available2
- Loose or Intermittent Connection1
- No Apparent Adverse Event1
Patient problems
- Insufficient Information3
- Failure of Implant1
- Joint Laxity1
- Limited Mobility Of The Implanted Joint1
- Pain1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2026No Apparent Adverse Event
Patient problems: Insufficient Information
MAUDE report 50876511 ↗InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT FELL.
Patient problems: Insufficient Information
MAUDE report 20092795 ↗InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 1, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO PATIENT COMPLAINED OF PAIN S/P LEFT TOTAL KNEE REPLACEMENT, DURING PHYSICAL THERAPY APPOINTMENT.
Patient problems: Pain
MAUDE report 13979732 ↗InjuryJun 30, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT COULD NOT GET FULL MOBILITY.
Patient problems: Limited Mobility Of The Implanted Joint
MAUDE report 10212138 ↗InjuryNov 21, 2019Loose or Intermittent Connection
REVISION SURGERY - THE TIBIAL COMPONENT HAD LOOSEN DUE TO LACK OF INGROWTH.
Patient problems: Failure of Implant
MAUDE report 9355828 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K171991. One submission often covers many models, so check the product and lot details in each record.
- Z-0508-2024 · Nov 10, 2023 · Open, ClassifiedDJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108
- Z-0258-2024 · Sep 29, 2023 · Open, ClassifiedDJO EMPOWR Knee Punch Handle, REF: 801-05-040
- Z-0060-2021 · Aug 3, 2020 · Open, ClassifiedDJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for EMPOWR Porous Knee - Product Usage: The Tibial Punch Handle is used in conj
Other PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices
- ATTUNE 1512-14-050Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER106 reports
- ATTUNE 1504-40-205Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall53 reports
- ATTUNE 1504-40-105Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall46 reports
- ATTUNE 1547-06-001Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall37 reports
- ATTUNE 1513-12-060Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER72 reports
- Triathlon 5521-B-300Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall19 reports
- Triathlon 5531-G-709-EHowmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall19 reports
- ATTUNE 1512-16-080Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 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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