DJO SURGICAL 385-09-506Recalls & reported problems
Encore Medical, L.P. · INSERT, STD., PRIMARY, SIZE6 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 00888912117746), received between Sep 15, 2016 and Jul 10, 2026 — classified as 9 injuries.
The most frequently reported specific device problem is “Naturally Worn” (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
- Naturally Worn3
- Adverse Event Without Identified Device or Use Problem2
- Loose or Intermittent Connection2
- Insufficient Device Problem Information1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Patient-Device Incompatibility1
Patient problems
- Unspecified Infection3
- Joint Laxity2
- No Code Available2
- Pain2
- Swelling1
- Synovitis1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryJul 10, 2026Naturally Worn
InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 15, 2022Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT HAD PAIN AND STIFFNESS IN THE LEFT KNEE. INFECTION WAS CHECKED VIA ASPIRATION. POLY ETHYLENE EXCHANGE WAS DETERMINED AS BEST COURSE OF ACTION. SURGERY WAS INITIALLY DONE, POLY DEBRIS MOST LIKELY CAUSING SYNOVITIS. IN SURGERY, SYNOVITIS FOUND. POLY ETHLENE AND PATELLA REPLACED.
Patient problems: Pain; Synovitis; Unspecified Infection
MAUDE report 13534224 ↗InjuryJul 6, 2020Naturally Worn
REVISION SURGERY - PATIENT HAD KNEE INSTABILITY. SURGEON DETERMINED IT WAS DUE TO POLY WEAR. SCHEDULED A POLY SWAP.
Patient problems: No Code Available
MAUDE report 10234329 ↗InjuryMar 17, 2020Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - PATIENT PRESENT WITH PAIN DUE TO LAXITY. SURGEON FELT A THICKER POLY WAS NEEDED.
Patient problems: Pain
MAUDE report 9843120 ↗InjuryDec 12, 2017Patient-Device Incompatibility
REVISION SURGERY - DUE TO THE PATIENT'S KNEE SWELLING. THE SURGEON REMOVED AND EXCHANGED OUT THE INSERT AND PATELLA.
Patient problems: Swelling
MAUDE report 7110414 ↗InjuryJun 6, 2017Loose or Intermittent Connection; Naturally Worn
REVISION SURGERY: THE PATIENT PRESENTED WITH LAXITY DUE TO POLY WEAR. THE SURGEON REPLACED THE POLY WITH A THICKER INSERT.
Patient problems: No Code Available
MAUDE report 6616411 ↗InjuryNov 19, 2016Insufficient Device Problem Information
REVISION SURGERY - DUE TO THE PATIENT WALKING BAREFOOT DOWN A HOT PAVED ROAD BURNING HER FEET, WHICH ALLOWED A MASSIVE INFECTION. ALL COMPONENTS HAD TO BE REMOVED. TEMPORARY "SPACE HOLDERS" ARE IN PLACE WITH ANTIBIOTICS.
Patient problems: Unspecified Infection
MAUDE report 6115690 ↗InjurySep 15, 2016Loose or Intermittent Connection
REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 5954639 ↗
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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