DJO SURGICAL 360-09-506Recalls & reported problems
Encore Medical, L.P. · FOUNDATION® KNEE SYSTEM PS Insert 9mm CM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888912116268), received between Feb 26, 2016 and Jan 27, 2026 — classified as 10 injuries.
The most frequently reported specific device problem is “Break” (2 reports).
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 Problem2
- Break2
- Unstable2
- Appropriate Device Problem Term/Code Not Available1
- Detachment Of Device Component1
- Device Dislodged or Dislocated1
- Naturally Worn1
- Patient Device Interaction Problem1
Patient problems
- No Code Available4
- Pain2
- Failure of Implant1
- Fall1
- Insufficient Information1
- Loss of Range of Motion1
- Unspecified Infection1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryJan 27, 2026Patient Device Interaction Problem
REVISION SURGERY - DUE TO THE POST OF THE FOUNDATION PS POLY HAS BROKEN OFF FROM A CASE 20 YEARS AGO.
Patient problems: Failure of Implant
MAUDE report 24196139 ↗InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - POST BROKE OFF TIBIAL INSERT. NOT SURE HOW. REPLACED WITH SAME SIZE.
Patient problems: Insufficient Information
MAUDE report 18500056 ↗InjuryJun 1, 2022Appropriate Device Problem Term/Code Not Available
InjuryDec 20, 2019Device Dislodged or Dislocated
REVISION SURGERY - DUE TO KNEE DISLOCATION.
Patient problems: No Code Available
MAUDE report 9503794 ↗InjuryApr 29, 2019Break
REVISION SURGERY - DUE TO POST OPERATIVE POSTERIOR STABILIZED (PS) INSERT BROKEN. PAINFUL AND UNSTABLE.
Patient problems: Pain
MAUDE report 8561952 ↗InjuryNov 20, 2018Unstable
REVISION SURGERY - DUE TO THE PATIENT HAVING INSTABILITY.
Patient problems: No Code Available
MAUDE report 8091429 ↗InjuryJun 22, 2018Naturally Worn
InjuryJul 31, 2017Break; Detachment Of Device Component
REVISION SURGERY - DUE TO THE POST BREAKING OFF FROM THE TIBIAL INSERT.
Patient problems: No Code Available
MAUDE report 6754166 ↗InjuryDec 22, 2016Unstable
REVISION SURGERY - DUE TO LOSS OF MOTION AND INSTABILITY; NEEDED REVISION.
Patient problems: Loss of Range of Motion
MAUDE report 6201613 ↗InjuryFeb 26, 2016Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION; REQUIRING REMOVAL AND REPLACEMENT.
Patient problems: Unspecified Infection
MAUDE report 5463780 ↗
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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