DJO SURGICAL 520-01-014Recalls & reported problems
Encore Medical, L.P. · TURON PRIMARY HUMERAL STEM, SZ 14 · 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 00888912024914), received between Sep 16, 2015 and Jul 22, 2024 — classified as 9 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
4 other recalls cover devices cleared under the same FDA submission (K080402); they may or may not involve this specific model.
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 Available3
- Device Dislodged or Dislocated1
- Device Operates Differently Than Expected1
- Loose or Intermittent Connection1
Patient problems
- Implant Pain2
- No Code Available2
- Unspecified Infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Complaint, Ill-Defined1
- Fracture, Arm1
- Pain1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 4, 2022Device Dislodged or Dislocated
REVISION SURGERY - THE TOTAL SHOULDER CAME OUT. PATIENT WAS SORE AND/OR KNOCKED SOMETHING LOOSE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14273589 ↗InjuryAug 13, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10401477 ↗InjuryJul 2, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - REMOVED ITEMS CHANGED TO RSP.
Patient problems: No Code Available
MAUDE report 10224689 ↗InjuryMay 30, 2018Appropriate Device Problem Term/Code Not Available
InjuryMar 13, 2018Device Operates Differently Than Expected
REVISION SURGERY - THE SURGEON SAID THIS WAS A FAILED SUBSCAPULARIS AND ROTATOR CUFF FAILURE. THE SURGEON PERFORMED A CONVERSION FROM ANATOMIC TOTAL SHOULDER ARTHROPLASTY TO REVERSE TOTAL SHOULDER ARTHROPLASTY.
Patient problems: No Code Available
MAUDE report 7335000 ↗InjurySep 16, 2015Loose or Intermittent Connection
SECOND REVISION SURGERY - THE PATIENT HAD LOTS OF PAIN IN JOINT, BONE LOSS IN JOINT AND THE PROSTHESIS WAS VERY LOOSE. PER THE REPRESENTATIVE, THE SURGEON REPLACED THE DJO PRODUCT WITH A BIOMET SHOULDER, NOT DJO PRODUCT.
Patient problems: Complaint, Ill-Defined; Pain
MAUDE report 5081882 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K080402. One submission often covers many models, so check the product and lot details in each record.
- Z-0800-2011 · Nov 5, 2010 · TerminatedTuron Shoulder System Instrumentation, Turon Trial Pegged Glenoid, DJO Surgical
- Z-0798-2011 · Nov 5, 2010 · TerminatedTuron Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical
- Z-0799-2011 · Nov 5, 2010 · TerminatedTuron Shoulder System Instrumentation, Turon Trial Humeral Neck, DJO Surgical
- Z-0801-2011 · Nov 5, 2010 · TerminatedTuron Shoulder System Instrumentation, Turon Pegged Glenoid Drill Guide, REF 804-25-024, DJO Surgical
Other Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 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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