DJO SURGICAL 520-01-012Recalls & reported problems
Encore Medical, L.P. · TURON PRIMARY HUMERAL STEM, SZ 12 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888912024907), received between Dec 23, 2015 and Sep 25, 2026 — classified as 14 injuries.
The most frequently reported specific device problem is “Unstable” (3 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 Problem8
- Unstable3
- Appropriate Device Problem Term/Code Not Available2
- Crack1
- Fracture1
- Patient-Device Incompatibility1
Patient problems
- Failure of Implant3
- Joint Laxity3
- Fall2
- Implant Pain2
- Bone Fracture(s)1
- Complaint, Ill-Defined1
- Excessive Tear Production1
- Insufficient Information1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50892490 ↗InjuryDec 26, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE STEM VERSION WAS OFF. SO THE TURON STEM WAS REMOVED AND A 175 RSP STEM WITH A HEMI CONVERSION MODULE WAS USED TO REPLACE IT.
Patient problems: Insufficient Information
MAUDE report 18794357 ↗InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT WAS DISLOCATING AFTER HER INITIAL PROCEDURE. SURGEON BELIEVED THE INITIAL STEM WAS PROND AND THE PATIENT WAS OVERSTUFFED CAUSING HER TO DISLOCATE ANTERIORLY. SURGEON DOWN SIDED THE STEM, AND USED THE SAME NECK AND HEAD.
Patient problems: Joint Dislocation
MAUDE report 15801376 ↗InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO SUBSCAP FAILURE, REMOVED ALL COMPONENTS AND INSTALLED DJO REVERSE SHOULDER.
Patient problems: Muscle/Tendon Damage
MAUDE report 15510442 ↗InjuryJun 30, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - ALL ITEMS REMOVED. NO DJO IMPLANTS PUT BACK IN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10212128 ↗InjuryOct 15, 2019Unstable; Appropriate Device Problem Term/Code Not Available
InjuryJun 1, 2017Fracture
REVISION SURGERY - AFTER THE INITIAL SURGERY THE PATIENT HAD A SEIZURE AND FRACTURED THE STEM. THE STEM NEEDED TO BE REPLACED DUE TO THE FALL.
Patient problems: Bone Fracture(s); Seizures
MAUDE report 6606069 ↗InjuryMay 8, 2017Patient-Device Incompatibility
REVISION SURGERY - DUE TO THE PATIENT FALLING AND TEARING HIS CUFF MUSCLES; SO HE WAS CONVERTED TO A REVERSE.
Patient problems: Excessive Tear Production; Failure of Implant; Fall
MAUDE report 6552645 ↗InjuryFeb 15, 2017Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PREVIOUS SURGERY FAILING, HEMI SHOULDER AND ROTATOR CUFF, THE SURGEON CONVERTED TO A REVERSE.
Patient problems: Failure of Implant
MAUDE report 6332168 ↗InjuryDec 23, 2015Crack
REVISION SURGERY - DUE TO THE HUMOROUS HAVING CRACKED. THE PATIENT SAID SHE DID NOT FALL BUT SHE DID HAVE POOR BONE QUALITY.
Patient problems: Complaint, Ill-Defined; Fall
MAUDE report 5324717 ↗
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-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
- 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
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.
How reports and recalls are matched · Editorial policy · Report an error on this page