DJO SURGICAL 520-01-006Recalls & reported problems
Encore Medical, L.P. · TURON PRIMARY HUMERAL STEM, SZ 6 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00888912144896), received between Aug 9, 2016 and Apr 1, 2026 — classified as 22 injuries.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (2 reports).
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 Problem12
- Appropriate Device Problem Term/Code Not Available5
- Device Operates Differently Than Expected2
- Insufficient Device Problem Information2
- Unstable1
Patient problems
- Unspecified Infection13
- Insufficient Information2
- Damage to Ligament(s)1
- Implant Pain1
- Joint Dislocation1
- Medical device site infection1
- No Code Available1
- No Information1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem
InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 11, 2024Unstable; Unstable
REVISION SURGERY DUE TO THE PATIENT BECOMING UNSTABLE.
Patient problems: Joint Dislocation
MAUDE report 20909649 ↗InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE TURON STEM AND HEAD WAS IMPLANTED AND USED AS A FUNCTIONAL ANTIBIOTIC CEMENT SPACER IN THIS PATIENT. IT REPLACED A COMPETITOR'S TOTAL SHOULDER ARTHROPLASTY CONSTRUCT THAT WAS INFECTED. THE CURRENT CASE, REMOVED THE TURON STEM AND HEAD AND THE SURGEON IMPLANTED AND ALTIVATE REVERSE SHOULDER.
Patient problems: Medical device site infection
MAUDE report 15917556 ↗InjuryJun 23, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WAS FOUND TO HAVE A SEVERE INFECTION DURING THE PRIMARY SURGERY, INTENDED REVERSE. SURGEON OPTED TO WRAP A TURON HEMI CONSTRUCT IN ANTIBIOTIC CEMENT. AFTER INFECTION SUBSIDED, HEMI ANTIBIOTIC SPACER WAS REMOVED AND REVISION TO REVERSE WAS PERFORMED.
Patient problems: Unspecified Infection
MAUDE report 12055231 ↗InjuryMar 8, 2021Appropriate Device Problem Term/Code Not Available
SECOND REVISION SURGERY - OLD PARTS USED AS AN ANTIBIOTIC CEMENT SPACER. PATIENT STARTED DRAINING. COMPLETE REMOVAL, IRRIGATION & DRAINAGE AND REIMPLANTATION OF NEW SPACER NECESSARY.
Patient problems: Insufficient Information
MAUDE report 11435670 ↗InjuryJan 7, 2020Adverse Event Without Identified Device or Use Problem
SECOND REVISION SURGERY - DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 9558872 ↗InjurySep 12, 2019Appropriate Device Problem Term/Code Not Available
THIRD REVISION SURGERY: THIS PATIENT HAS BEEN REVISED THREE DIFFERENT OCCASIONS SINCE HIS ORIGINAL DATE OF SURGERY. THE ORIGINAL SURGERY WAS AN REVERSE SHOULDER PROSTHESIS AND NEEDED TO BE REVISED. PATIENT WAS REVISED NEARLY A YEAR AND A HALF LATER. ALL REVERSE SHOULDER PROSTHESIS COMPONENTS WERE REMOVED AND HEMI CEMENT COATED SPACER WAS PLACED TO COMBAT INFECTION, ALL COMPONENTS ARE BEING REMOVED AND REPLACED WITH STANDARD REVERSE SHOULDER PROSTHESIS COMPONENTS.
Patient problems: Unspecified Infection
MAUDE report 9010363 ↗InjuryFeb 21, 2019Appropriate Device Problem Term/Code Not Available
InjuryNov 9, 2017Device Operates Differently Than Expected
REVISION SURGERY - DUE TO A FAILED HEMI. THE SURGEON CONVERTED TO A REVERSE.
Patient problems: No Information
MAUDE report 7014211 ↗InjuryOct 26, 2017Insufficient Device Problem Information
REVISION SURGERY - REVISION TO A REVERSE SHOULDER BECAUSE OF PATIENT ROTATOR CUFF TEAR.
Patient problems: No Code Available
MAUDE report 6980003 ↗InjuryApr 22, 2017Insufficient Device Problem Information
REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION; THE SURGEON USED IMPLANTS AS AN ANTIBIOTIC SPACER.
Patient problems: Unspecified Infection
MAUDE report 6514823 ↗InjuryMar 16, 2017Device Operates Differently Than Expected
REVISION SURGERY - DUE TO THE PATIENT HAVING A TORN ROTATOR CUFF.
Patient problems: Damage to Ligament(s)
MAUDE report 6409469 ↗InjuryFeb 22, 2017Adverse Event Without Identified Device or Use Problem
THIRD REVISION SURGERY - DUE TO THE PATIENT HAVING A CHRONIC INFECTION.
Patient problems: Unspecified Infection
MAUDE report 6350742 ↗InjuryAug 9, 2016Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT WAS INFECTED FROM PREVIOUS SURGERY, SO THE SURGEON REMOVED THE CURRENT IMPLANTS AND REPLACED THEM WITH NEW COMPONENTS EXCEPT FOR THE PEGGED POLY.
Patient problems: Unspecified Infection
MAUDE report 5857225 ↗
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-0798-2011 · Nov 5, 2010 · TerminatedTuron Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical
- Z-0800-2011 · Nov 5, 2010 · TerminatedTuron Shoulder System Instrumentation, Turon Trial Pegged Glenoid, DJO Surgical
- Z-0801-2011 · Nov 5, 2010 · TerminatedTuron Shoulder System Instrumentation, Turon Pegged Glenoid Drill Guide, REF 804-25-024, DJO Surgical
- Z-0799-2011 · Nov 5, 2010 · TerminatedTuron Shoulder System Instrumentation, Turon Trial Humeral Neck, 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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