DJO SURGICAL 520-01-010Recalls & reported problems
Encore Medical, L.P. · TURON PRIMARY HUMERAL STEM, SZ 10 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888912024891), received between Dec 23, 2015 and Mar 2, 2026 — classified as 15 injuries.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 Problem4
- Appropriate Device Problem Term/Code Not Available3
- Loose or Intermittent Connection2
- Unstable2
- Device Operates Differently Than Expected1
- Insufficient Device Problem Information1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Naturally Worn1
Patient problems
- Failure of Implant3
- No Code Available3
- Pain3
- Unspecified Infection3
- Joint Laxity1
- No Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem
InjuryOct 6, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 23, 2022Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - REMOVAL OF ALL ORIGINAL IMPLANTS DUE TO STEM WAS LOOSE.
Patient problems: Failure of Implant
MAUDE report 15276918 ↗InjuryMar 20, 2019Appropriate Device Problem Term/Code Not Available
InjuryFeb 1, 2019Loose or Intermittent Connection
REVISION SURGERY - DUE TO LOOSENING OF COMPONENTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8297872 ↗InjuryOct 17, 2018Unstable
REVISION SURGERY - DUE TO THE PATIENT HAVING A HEMI-ARTHROPLASTY PERFORMED THAT DID NOT ACHIEVE THE PAIN CONTROL EXPECTED. THE PATIENT PRESENTED TO THE SURGEON WITH PAIN AND INSTABILITY THAT WAS CORRECTED THROUGH REMOVING ALL IMPLANTS AND REPLACING WITH A REVERSE TOTAL SHOULDER.
Patient problems: Pain
MAUDE report 7973438 ↗InjuryJul 19, 2017Device Operates Differently Than Expected
InjuryMay 16, 2017Loose or Intermittent Connection
REVISION SURGERY - DUE TO THE HUMERAL STEM LOOSENING.
Patient problems: No Code Available
MAUDE report 6570993 ↗InjuryMay 15, 2017Naturally Worn
Patient problems: Failure of Implant
MAUDE report 6567673 ↗InjuryJan 4, 2017Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - REVISION OF A PREVIOUS HEMI ARTHROPLASTY TO A TOTAL SHOULDER ARTHROPLASTY.
Patient problems: No Code Available
MAUDE report 6222935 ↗InjuryNov 3, 2016Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THERE WAS NO PRODUCT ISSUE. THE PARTS REPORTED ON THIS REPORT WERE USED AS A TEMPORARY SPACER WHILE THE PATIENT WAS TREATED FOR AN INFECTION WHICH WAS FOUND DURING THE ORIGINAL SURGERY ON (B)(6) 2016.
Patient problems: Unspecified Infection
MAUDE report 6076682 ↗InjuryMar 24, 2016Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT SUFFERING FROM PAIN; THE SURGEON REVISED FROM A HEMI ARTHROPLASTY TO A REVERSE SHOULDER.
Patient problems: Pain
MAUDE report 5522059 ↗InjuryMar 21, 2016Insufficient Device Problem Information
REVISION SURGERY - DUE TO THE PATIENT HAVING A SUBSCAPULAR FAILURE; THE OLD IMPLANTS WERE REMOVED AND NEW ONES WERE PLACED.
Patient problems: Failure of Implant
MAUDE report 5515064 ↗InjuryDec 23, 2015Torn Material
REVISION SURGERY - DUE TO THE PATIENT HAVING A SUB SCAPULAR AND ROTATOR CUFF TEAR.
Patient problems: No Code Available
MAUDE report 5324923 ↗
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-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-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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