DJO SURGICAL 520-01-008Recalls & reported problems
Encore Medical, L.P. · TURON PRIMARY HUMERAL STEM, SZ 8 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888912144902), received between Jan 12, 2018 and Aug 27, 2025 — classified as 13 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 Problem5
- Appropriate Device Problem Term/Code Not Available5
- Insufficient Device Problem Information1
- Patient-Device Incompatibility1
- Unintended Movement1
Patient problems
- Unspecified Infection4
- Failure of Implant3
- Pain2
- Implant Pain1
- Injury1
- Joint Laxity1
- Loss of Range of Motion1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 6, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO ROTATOR CUFF FAILURE, NEEDED TO REPLACE ANATOMIC WITH A REVERSE.
Patient problems: Failure of Implant
MAUDE report 14605733 ↗InjuryNov 7, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT PRESENTED TO SURGEON WITH PAIN AN LOSS OF MOTION IN HIS RIGHT SHOULDER. PATIENT HAD A TOTAL SHOULDER. BASED ON FINDINGS THE PATIENT AGREED TO HAVE A REVISION OF HIS SHOULDER. THE IMPLANTS WERE REMOVED AND REPLACED.
Patient problems: Loss of Range of Motion
MAUDE report 12759057 ↗InjuryJun 8, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - TOTAL SHOULDER FAILED DUE TO CUFF TEAR; NEEDED TO BE CONVERTED TO A REVERSE SHOULDER.
Patient problems: Failure of Implant
MAUDE report 11961687 ↗InjuryMay 26, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAS BEEN CHRONICALLY INFECTED, SO SURGEON DID A STAGED PROCEDURE. THE PATIENT'S INFECTION SEEMED TO BE RESOLVED AND THE SURGEON REVISED HIM TO A REVERSE SHOULDER.
Patient problems: Unspecified Infection
MAUDE report 11882465 ↗InjuryMar 31, 2021Unintended Movement
REVISION SURGERY - PATIENT HAD A MOVING VEHICLE ACCIDENT THAT CAUSED SEVERE PAIN IN SHOULDER. THERE WAS NOTICEABLE DISTAL MOVEMENT OF HUMERAL STEM. REVISION SURGERY WAS REQUIRED TO REPLACE STEM, CONVERSION SHELL,AND SOCKET INSERT.
Patient problems: Pain
MAUDE report 11596399 ↗InjuryApr 11, 2019Patient-Device Incompatibility
InjuryFeb 19, 2018Insufficient Device Problem Information
REVISION SURGERY - DUE TO THE PATIENT HAVING A ROTATOR CUFF TEAR. THE SURGEON REMOVED ALL ORIGINAL IMPLANTS AND CONVERTED TO A REVERSE SHOULDER.
Patient problems: Injury
MAUDE report 7281191 ↗InjuryJan 12, 2018Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT HAVING A FAILED ROTATOR CUFF. THE SURGEON FELT HE NEEDED TO CONVERT FROM ANATOMIC TO REVERSE PROSTHESIS.
Patient problems: Failure of Implant
MAUDE report 7185727 ↗
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-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-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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