DJO SURGICAL 385-09-504Recalls & reported problems
Encore Medical, L.P. · INSERT, STD., PRIMARY, SIZE4 9MM CM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888912117722), received between Aug 18, 2016 and Feb 11, 2026 — classified as 9 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information3
- Appropriate Device Problem Term/Code Not Available2
- Unstable2
- Adverse Event Without Identified Device or Use Problem1
- Loose or Intermittent Connection1
Patient problems
- Pain3
- Unspecified Infection3
- Bone Fracture(s)1
- Fall1
- Loss of Range of Motion1
- No Code Available1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT HAD A TOTAL KNEE DONE IN 2014. RECENTLY HAD A SEVERE FALL AND FRACTURE THEIR FEMUR.
Patient problems: Bone Fracture(s); Fall
MAUDE report 24319159 ↗InjuryMar 30, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO SINUS INFECTION THAT SPREAD. SURGEON PERFORMED IRRIGATION & DRAINAGE AND REPLACED POLY DURING CLEAN OUT.
Patient problems: Unspecified Infection
MAUDE report 13956083 ↗InjuryApr 9, 2020Unstable
SECOND REVISION SURGERY - PATIENT PRESENTED 12 YEARS POST OPERATION WITH PAIN DUE TO LAXITY. SURGEON WANTED THICKER POLY.
Patient problems: Pain
MAUDE report 9943676 ↗InjuryNov 21, 2018Unstable
REVISION SURGERY - DUE TO THE PATIENT PRESENTING TO THE SURGEON WITH INSTABILITY.
Patient problems: No Code Available
MAUDE report 8096507 ↗InjuryJan 12, 2018Insufficient Device Problem Information
REVISION SURGERY - DUE TO THE PATIENT BEING PRESENTED WITH PAIN DUE TO LAXITY.
Patient problems: Pain
MAUDE report 7186680 ↗InjuryAug 30, 2017Insufficient Device Problem Information
REVISION SURGERY - DUE TO THE PATIENT'S KNEE HAVING LACK OF MOTION.
Patient problems: Loss of Range of Motion
MAUDE report 6832302 ↗InjuryJun 30, 2017Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: DUE TO THE PATIENT HAVING ANKLE SURGERY TWO WEEKS AGO WHICH BECAME INFECTED AND SPREAD TO HER KNEE. THE SURGEON REMOVED THE IMPLANTS AND WASHED OUT THE KNEE.
Patient problems: Unspecified Infection
MAUDE report 6682692 ↗InjuryMay 26, 2017Loose or Intermittent Connection
REVISION SURGERY - DUE TO THE PATIENT PRESENTING WITH LAXITY AND MEDIAL PAIN. THE SURGEON DECIDED TO INCREASE THE THICKNESS OF THE INSERT.
Patient problems: Pain
MAUDE report 6594227 ↗InjuryAug 18, 2016Insufficient Device Problem Information
REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION; THE SURGEON EXCHANGED THE ORIGINAL INSERT.
Patient problems: Unspecified Infection
MAUDE report 5886575 ↗
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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