DJO SURGICAL 520-50-118Recalls & reported problems
Encore Medical, L.P. · HEAD, HUMERAL, OFFSET, 50-18 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888912025058), received between Jan 14, 2016 and Nov 12, 2024 — classified as 11 injuries.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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
- Device Operates Differently Than Expected3
- Adverse Event Without Identified Device or Use Problem2
- Insufficient Device Problem Information2
- Loose or Intermittent Connection1
- Material Erosion1
- Patient-Device Incompatibility1
- Torn Material1
Patient problems
- No Code Available7
- Pain2
- Insufficient Information1
- Joint Dislocation1
- Loss of Range of Motion1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO ISSUE WITH EXTERNAL ROTATION OF SHOULDER.
Patient problems: Joint Dislocation; Loss of Range of Motion
MAUDE report 20670018 ↗InjuryMay 17, 2021Loose or Intermittent Connection
REVISION SURGERY - SURGEON TOOK OUT A LOOSE TURON GLENOID. HE WAS DOING A SHOULDER SCOPE AND SINCE THE GLENOID COMPONENT WAS LOOSE, HE JUST TOOK IT OUT DURING THE SCOPE PROCEDURE. HE DID NOT REPLACE IT WITH ANYTHING. HE MAY REVISE TO A REVERSE AT A LATER DATE.
Patient problems: Insufficient Information
MAUDE report 11832657 ↗InjuryDec 19, 2018Patient-Device Incompatibility
REVISION SURGERY -THE PATIENT WAS IN PAIN AND TOO TIGHT. THE SURGEON PERFORMED A HEAD AND NECK EXCHANGE; DOWNSIZED THE HEAD.
Patient problems: Pain
MAUDE report 8180914 ↗InjuryMar 29, 2018Device Operates Differently Than Expected
REVISION SURGERY - DUE TO A FAILED ROTATOR CUFF. THE SURGEON CONVERTED TO A REVERSE.
Patient problems: No Code Available
MAUDE report 7383382 ↗InjuryFeb 6, 2018Insufficient Device Problem Information
REVISION SURGERY - DUE TO THE SURGEON CONVERTING A TURON HEMI-ARTHROPLASTY TO A REVERSE TOTAL SHOULDER ARTHROPLASTY.
Patient problems: No Code Available
MAUDE report 7244567 ↗InjuryNov 16, 2017Device Operates Differently Than Expected
REVISION SURGERY - DUE TO AN ISSUE WITH COMPETITOR GLENOID PART. THIS WAS A MULTI-VENDOR CASE.
Patient problems: No Code Available
MAUDE report 7037081 ↗InjuryJul 20, 2017Adverse Event Without Identified Device or Use Problem
REVISION SURGERY: DUE TO THE PATIENT COMPLAINING ABOUT PAIN. THE SURGEON BELIEVED THE PAIN WAS CAUSED BY AN OVERSTUFFING OF THE HUMERAL HEAD.
Patient problems: Pain
MAUDE report 6730573 ↗InjuryMay 19, 2017Torn Material
REVISION SURGERY - DUE TO THE PATIENT HAVING A TEAR IN THEIR ROTATOR CUFF. THE SURGEON REMOVED ALL OF THE TURON IMPLANTS AND PUT IN A TOTAL REVERSE SHOULDER.
Patient problems: No Code Available
MAUDE report 6578969 ↗InjuryFeb 11, 2016Insufficient Device Problem Information
REVISION SURGERY - DUE TO AN IRREPARABLE ROTATOR CUFF TEAR. THE SURGEON REPLACED THE TURON SHOULDER WITH A REVERSE SHOULDER PROSTHESIS.
Patient problems: No Code Available
MAUDE report 5431188 ↗InjuryFeb 4, 2016Material Erosion
REVISION SURGERY - DUE TO THE PATIENT'S GLENOID HAVING ERODED; THE SURGEON PERFORMED A REVISION FOR A NEW HEAD WITH A PEGGED GLENOID.
Patient problems: No Code Available
MAUDE report 5410901 ↗InjuryJan 14, 2016Device Operates Differently Than Expected
REVISION SURGERY - DUE TO A CUFF TEAR CAUSING JOINT FAILURE; REQUIRING A REVISION TO A REVERSE PROSTHESIS.
Patient problems: No Code Available
MAUDE report 5369000 ↗
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-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
- 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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