DJO SURGICAL 520-42-016Recalls & reported problems
Encore Medical, L.P. · HEAD, HUMERAL, NEUTRAL, 42-16 · 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 00888912145114), received between Dec 23, 2015 and Jun 29, 2026 — classified as 14 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 Problem6
- Appropriate Device Problem Term/Code Not Available3
- Device Dislodged or Dislocated2
- Defective Device1
- Device Operates Differently Than Expected1
- Patient Device Interaction Problem1
Patient problems
- No Code Available4
- Insufficient Information2
- Joint Dislocation2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Excessive Tear Production1
- Failure of Implant1
- Joint Laxity1
- Loss of Range of Motion1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjuryJun 29, 2026Device Dislodged or Dislocated
InjuryJan 30, 2026Patient Device Interaction Problem
REVISION SURGERY - DUE TO FAILED GLENOID.
Patient problems: Failure of Implant
MAUDE report 24228987 ↗InjuryAug 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT HAD A HEMI-SHOULDER PUT IN ON (B)(6) 2020. CONVERTED IT TO A FULL REVERSE ON (B)(6) 2023.
Patient problems: Insufficient Information
MAUDE report 17569120 ↗InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - CONVERTED FROM TOTAL TO REVERSE BECAUSE OF CUFF TEAR.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11454838 ↗InjuryFeb 18, 2021Adverse Event Without Identified Device or Use Problem
SECOND REVISION SURGERY - PATIENT HAD A KNEE INFECTION THAT MOVED TO THE SHOULDER. SO SHOULDER IMPLANT NEEDED TO BE TAKEN OUT AND A NEW IMPLANT WAS PUT IN.
Patient problems: Unspecified Infection
MAUDE report 11342724 ↗InjuryJan 4, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO PATIENT WAS DIAGNOSED FOR CONVERSION FROM HEMI SHOULDER TO A REVERSE SHOULDER. REMOVED THE HUMERAL HEAD.
Patient problems: Insufficient Information
MAUDE report 11114060 ↗InjuryJun 13, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - SURGEON REMOVED GLENOID, HEAD, AND NECK OF A TURON AND CONVERTED IT TO A REVERSE.
Patient problems: No Information
MAUDE report 8697701 ↗InjuryMay 24, 2019Defective Device
REVISION SURGERY - DUE TO A 2 CENTIMETER DEFECT IN GLENOID. THE SURGEON REMOVED THESE COMPONENTS AND IMPLANTED A 12 X 108 ALTIVATE STANDARD BOWL STEM, 36 NEUTRAL HEAD AND 36 STANDARD POLY.
Patient problems: No Code Available
MAUDE report 8641115 ↗InjuryMar 15, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WAS IMPLANTED WITH A SMALL SHELL REVERSE STEM AS A HEMI UNTIL GLENOID BONE GRAFT INCORPORATED. THE SURGEON IMPLANTED A 32-4 GLENOSPHERE AND SOCKET INSERT.
Patient problems: No Code Available
MAUDE report 8426191 ↗InjuryJan 8, 2018Device Operates Differently Than Expected
REVISION SURGERY - DUE TO POOR RANGE OF MOTION. THE SURGEON CONVERTED A HEMI TO A REVERSE.
Patient problems: Loss of Range of Motion; No Code Available
MAUDE report 7171681 ↗InjuryOct 19, 2017Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT TEARING THEIR ROTATOR CUFF, 4 YEARS POST SURGERY.
Patient problems: Excessive Tear Production
MAUDE report 6961317 ↗InjuryJan 30, 2016Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT HAVING ROTATOR CUFF ARTHROPATHY.
Patient problems: No Code Available
MAUDE report 5400137 ↗InjuryDec 23, 2015Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT DISLOCATING AFTER THEIR TURON SHOULDER SURGERY. THE SURGEON REMOVED THE TURON COMPONENTS AND REPLACED THEM WITH A REVERSE SHOULDER.
Patient problems: Joint Dislocation
MAUDE report 5325012 ↗
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-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-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.
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