DJO SURGICAL 385-11-508Recalls & reported problems
Encore Medical, L.P. · INSERT, STD., PRIMARY, SIZE8 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 00888912117876), received between Sep 16, 2015 and May 12, 2025 — classified as 7 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 Problem3
- Appropriate Device Problem Term/Code Not Available2
- Insufficient Device Problem Information2
- Unstable2
Patient problems
- Joint Laxity3
- Unspecified Infection2
- Implant Pain1
- Insufficient Information1
- Rupture1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryMay 12, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 18, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PAIN AND LAXITY.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 17962372 ↗InjuryJan 20, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - AS THE PATIENT APPARENTLY FELT UNSTABLE AND WAS REVISED TO A THICKER POLY.
Patient problems: Insufficient Information
MAUDE report 13311662 ↗InjuryDec 13, 2019Appropriate Device Problem Term/Code Not Available
InjuryMay 11, 2017Insufficient Device Problem Information
REVISION SURGERY - THE PATIENT HAD A FOUNDATION KNEE. THE SURGEON WENT IN TO FIX THE PATIENT'S RUPTURED EXTENSOR MECHANISM, THAT WAS NOT DIRECTLY EFFECTED BY A DJO PRODUCT. HE DECIDED TO INSERT A THICKER POLY IN THE PROCESS.
Patient problems: Rupture
MAUDE report 6560324 ↗InjurySep 16, 2015Insufficient Device Problem Information
REVISION SURGERY - THE SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT PROCEDURE DUE TO AN INFECTION. THE JOINT WAS WASHED OUT AND THE POLY EXCHANGED.
Patient problems: Unspecified Infection
MAUDE report 5081963 ↗
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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