DJO SURGICAL 391-09-610Recalls & reported problems
Encore Medical, L.P. · INSERT, 3D SIZE10 X 9MM L DCM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888912118903), received between Mar 22, 2016 and Jun 29, 2026 — classified as 15 injuries.
The most frequently reported specific device problem is “Naturally Worn” (5 reports).
5 other recalls cover devices cleared under the same FDA submission (K020114); 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
- Naturally Worn5
- Adverse Event Without Identified Device or Use Problem4
- Unstable4
- Appropriate Device Problem Term/Code Not Available1
- Insufficient Device Problem Information1
- Loose or Intermittent Connection1
Patient problems
- No Code Available5
- Joint Laxity4
- Unspecified Infection2
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
- Pain1
- Scar Tissue1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
InjuryJun 29, 2026Naturally Worn
InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem
InjuryJan 23, 2026Naturally Worn
InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 10, 2021Naturally Worn; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO POLY WEAR.
Patient problems: Insufficient Information
MAUDE report 12976147 ↗InjuryJun 12, 2019Naturally Worn
InjuryOct 18, 2018Loose or Intermittent Connection
REVISION SURGERY - DUE TO THE PATIENT BEING PRESENTED 12 YEARS POST OPERATIVE WITH LAXITY AND PAIN. THE SURGEON FELT IT WAS POLY WEAR.
Patient problems: Pain
MAUDE report 7981515 ↗InjuryApr 4, 2018Unstable
REPORTED INCIDENT - DUE TO A FAILED LEFT TOTAL KNEE ARTHROPLASTY (TKA), DEVICE INSTABILITY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7397355 ↗InjurySep 8, 2017Unstable
REVISION SURGERY - DUE TO THE PATIENT'S KNEE BEING UNSTABLE; THE SURGEON REMOVED AND EXCHANGED OUT THE ORIGINAL INSERT.
Patient problems: No Code Available
MAUDE report 6853823 ↗InjuryAug 23, 2017Unstable
REVISION SURGERY: DUE TO THE PATIENT HAVING INSTABILITY IN THE KNEE.
Patient problems: No Code Available
MAUDE report 6815071 ↗InjuryJan 11, 2017Unstable
REVISION SURGERY. DUE TO THE PATIENT BECOMING UNSTABLE.
Patient problems: No Code Available
MAUDE report 6244471 ↗InjuryJan 11, 2017Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT HAVING SCAR TISSUE.
Patient problems: Scar Tissue
MAUDE report 6244388 ↗InjuryNov 19, 2016Insufficient Device Problem Information
REVISION SURGERY - DUE TO THE PATIENT DEVELOPING AN INFECTION IN HIS KNEE TWO WEEKS POST-OPERATION.
Patient problems: Unspecified Infection
MAUDE report 6115674 ↗InjuryMar 22, 2016Naturally Worn
REVISION SURGERY - DUE TO POLY WEAR AND DELAMINATION OF THE MEDIAL COMPARTMENT.
Patient problems: No Code Available
MAUDE report 5515938 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K020114. One submission often covers many models, so check the product and lot details in each record.
- Z-2244-2010 · Jun 28, 2010 · Terminated3DKnee Baseplates, Size 8, Left, Part # 333-01-108, Lot# A1000003.
- Z-1433-2010 · Mar 19, 2010 · Terminated3DKNEE SYSTEM, 3D Knee Tibial Insert-DCM, Sterile, Right, size 4 x 11mm. Encore Medical, LP. Austin, TX 78758-5445. Intended to aid the surgion in relieving the patient of knee
- Z-1539-2008 · Feb 20, 2008 · Terminated3DKNEE Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; manufactured by Encore Medical, L.P., Austin, TX 78758. Used in surgery to determine the correct size of 3DKnee
- Z-0332-06 · Nov 3, 2005 · TerminatedSize 8 right 3DKnee Non-porous Baseplates (Catalog #333-02-108) joint knee replacement.
- Z-1011-04 · May 10, 2004 · Terminated3DKnee System, Stemmed Tibia-Nonporous-3D, Size 6, Right, sterile. Manufactured by Encore Orthopeadics, 9800 Metric Blvd., Austin, Texas 78758
Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices
- ATTUNE 1506-00-005Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER589 reports
- ATTUNE 1506-00-004Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER580 reports
- JOURNEY 74012812Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER502 reports
- JOURNEY 74011856Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER438 reports
- PERSONA™ 42-5099-094-00Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER406 reports
- JOURNEY 74011857Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER388 reports
- ATTUNE 1506-00-007Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER288 reports
- ATTUNE 1506-00-003Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER271 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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