DJO SURGICAL 385-11-506Recalls & reported problems
Encore Medical, L.P. · INSERT, STD., PRIMARY, SIZE6 11MM CM · 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 00888912117852), received between Apr 20, 2016 and Jul 9, 2025 — classified as 7 injuries.
The most frequently reported specific device problem is “Unstable” (3 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
- Appropriate Device Problem Term/Code Not Available4
- Unstable3
- Adverse Event Without Identified Device or Use Problem1
- Naturally Worn1
Patient problems
- Insufficient Information2
- Discomfort1
- Joint Laxity1
- Limited Mobility Of The Implanted Joint1
- No Code Available1
- Pain1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryJul 9, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMay 19, 2022Unstable
REVISION SURGERY - DUE TO INSTABILITY.
Patient problems: Insufficient Information
MAUDE report 14436682 ↗InjuryMar 29, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: DUE TO CHRONIC PAIN AND INSTABILITY. SURGEON DETERMINED THICKER INSERT WAS NEEDED.
Patient problems: Pain
MAUDE report 13942541 ↗InjuryApr 30, 2021Naturally Worn; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO POLY WEAR.
Patient problems: Insufficient Information
MAUDE report 11758015 ↗InjuryJun 21, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT PRESENTING AT SURGEONS OFFICE WITH KNEE DISCOMFORT AND INSTABILITY. UPON XRAY, SURGEON DETERMINED THERE WAS POLY WEAR.
Patient problems: Discomfort
MAUDE report 8724735 ↗InjuryJan 5, 2018Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO PATIENT'S LEG NOT FULLY EXTENDING. IT WAS TIGHT IN EXTENSION.
Patient problems: Limited Mobility Of The Implanted Joint
MAUDE report 7167680 ↗InjuryApr 20, 2016Unstable
REVISION SURGERY - DUE TO INSTABILITY; THE SURGEON EXCHANGED THE POLY.
Patient problems: No Code Available
MAUDE report 5592558 ↗
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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