DJO SURGICAL 385-13-504Recalls & reported problems
Encore Medical, L.P. · INSERT, STD., PRIMARY, SIZE4 13MM 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 00888912117920), received between Feb 10, 2017 and Mar 13, 2025 — classified as 7 injuries.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Loose or Intermittent Connection1
- Naturally Worn1
- Unstable1
Patient problems
- Joint Laxity2
- Implant Pain1
- Insufficient Information1
- Loss of Range of Motion1
- No Code Available1
- Pain1
- Scar Tissue1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryMar 13, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO POLY WEAR AND INSTABILITY.
Patient problems: Joint Laxity
MAUDE report 21601952 ↗InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 25, 2021Break; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - REVISION OF THE INSERT POLY IN A FOUNDATION ENCORE KNEE DONE IN 2005. THE EXISTING POLY BROKE DOWN MEDIALLY AND NEEDED TO BE REPLACED.
Patient problems: Insufficient Information
MAUDE report 11380066 ↗InjuryNov 14, 2017Loose or Intermittent Connection
REVISION SURGERY - DUE TO THE PATIENT COMPLAINING OF LAXITY IN HER TOTAL KNEE.
Patient problems: No Code Available
MAUDE report 7028028 ↗InjuryNov 1, 2017Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE SURGEON DID A POLY EXCHANGE DUE TO RANGE OF MOTION WITH SCAR TISSUE.
Patient problems: Loss of Range of Motion; Scar Tissue
MAUDE report 6994323 ↗InjuryFeb 10, 2017Naturally Worn
REVISION SURGERY - DUE TO THE PATIENT PRESENTING WITH PAIN. THE SURGEON FELT IT WAS DUE TO POLY WEAR (9 1/2 YEARS POST OPERATION). THE SURGEON REPLACED THE POLY AND DECIDED TO GO WITH AN ULTRA CONGRUENT OPTION.
Patient problems: Pain
MAUDE report 6322175 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page