DJO SURGICAL 520-50-022Recalls & reported problems
Encore Medical, L.P. · HEAD, HUMERAL, NEUTRAL, 50-22 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888912145213), received between Sep 13, 2017 and Oct 29, 2025 — classified as 9 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Appropriate Device Problem Term/Code Not Available1
- Device Dislodged or Dislocated1
- Device Operates Differently Than Expected1
- Insufficient Device Problem Information1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Material Separation1
- Unstable1
Patient problems
- No Code Available3
- Fall1
- Implant Pain1
- Joint Laxity1
- Loss of Range of Motion1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryOct 29, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO POOR RANGE OF MOTION.
Patient problems: Loss of Range of Motion
MAUDE report 17695933 ↗InjuryJun 9, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - REVISED TO REVERSE AFTER INFECTION WAS CLEARED UP. REMOVED HEMI HEAD & HEMI ADAPTER. IMPLANTED POLY INSERT & BASEPLATE/GLENOSPHERE. THE IMPLANTS REMOVED DID NOT CAUSE THE REVISION. INFECTION (POST OPERATIVELY) CAUSED THE REVISION.
Patient problems: Unspecified Infection
MAUDE report 14646006 ↗InjuryOct 13, 2021Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - PATIENT COMPLAIN OF HAVING PAIN AND LOOSENS.
Patient problems: Pain
MAUDE report 12627185 ↗InjuryNov 20, 2018Device Dislodged or Dislocated
SECOND REVISION SURGERY - DUE TO THE PATIENT BEING NON-COMPLIANT HAVING ALSO HAVING VERY UNSTABLE SOFT TISSUE. AN ORIGINAL REVERSE WAS DONE WHEN THE PATIENT DID NOT GO TO PHYSICAL THERAPY NOR FOLLOW INSTRUCTIONS. PATIENT LATER HAD OPENED REDUCTION FOR DISLOCATION. THE PATIENT WAS THEN CONVERTED TO HEMI AFTER ANOTHER DISLOCATION (NON-COMPLIANCE). THIS TIME THE SURGEON PERFORMED SOFT TISSUE GRAPHING AND WENT WITH A SMALLER HEAD.
Patient problems: No Code Available
MAUDE report 8091616 ↗InjuryMar 20, 2018Device Operates Differently Than Expected
REVISION SURGERY - DUE TO A SUBSCAPULARY FAILURE. THE SURGEON CONVERTED TO A REVERSE SHOULDER ARTHROPLASTY.
Patient problems: No Code Available
MAUDE report 7354870 ↗InjuryMar 12, 2018Insufficient Device Problem Information
REVISION SURGERY - DUE TO A CUFF TEAR NEEDING TO BE CONVERTED TO A REVERSE.
Patient problems: No Code Available
MAUDE report 7331786 ↗InjurySep 13, 2017Material Separation
REVISION SURGERY - DUE TO THE PATIENT HAVING A FALL THAT CAUSED THE TURON HEAD TO SEPARATE FROM THE STEM/HEMI ADAPTOR.
Patient problems: Fall
MAUDE report 6862480 ↗
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-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
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 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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