DJO SURGICAL 520-50-122Recalls & reported problems
Encore Medical, L.P. · HEAD, HUMERAL, OFFSET, 50-22 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888912025065), received between Aug 12, 2017 and Jul 11, 2025 — classified as 6 injuries.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 Problem3
- Device Operates Differently Than Expected1
- Patient-Device Incompatibility1
- Torn Material1
Patient problems
- Pain2
- Failure of Implant1
- Joint Dislocation1
- Joint Laxity1
- Loss of Range of Motion1
- No Code Available1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO IMPLANT FAILURE.
Patient problems: Failure of Implant
MAUDE report 22487405 ↗InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 11, 2018Device Operates Differently Than Expected
REVISION SURGERY - DUE TO THE PATIENT FEELING PAIN AND NOT HAVING GOOD FUNCTION.
Patient problems: Pain
MAUDE report 7183517 ↗InjuryDec 7, 2017Torn Material
REVISION SURGERY - DUE TO A TORN ROTATOR CUFF. THE SURGEON REVISED THE PRIMARY SHOULDER TO A REVERSE SHOULDER. NO ISSUES WITH IMPLANT OR INSTRUMENTS.
Patient problems: No Code Available
MAUDE report 7097840 ↗InjuryAug 12, 2017Patient-Device Incompatibility
REVISION SURGERY - DUE TO THE PATIENT PRESENTING TO THE SURGEON WITH PAIN AND LOSS OF MOTION IN THE RIGHT SHOULDER. UPON INSPECTION AND X-RAYS, THE SURGEON DETERMINED THE PATIENT HAD A CUFF TEAR AND RECOMMENDED A REVERSE TOTAL SHOULDER TO REDUCE PAIN AND REGAIN RANGE OF MOTION. THE SURGEON PERFORMED THE SURGERY USING HIS STANDARD DELTO-PECTORAL INCISION TO GAIN ACCESS TO THE JOINT. ONCE THE IMPLANTS WERE EXPOSED HE REMOVED THE HEAD (520-50-122) AND HUMERAL NECK (520-00-000), THEN ASSESSED THE HUMERAL STEM AND REMOVED THE POLYETHYLENE GLENOID (520-01-250). HE THEN PROCEED TO IMPLANT A GLENOID BASEPLATE AND FOUR SCREWS. HE THEN TRIALED 3 HEADS AND THE TURON-TO-RSP CONVERSION SHELL TO DETERMINE THE FINAL IMPLANTS. ONCE COMFORTABLE WITH STABILITY AND RANGE-OF-MOTION THE SURGEON IMPLANTED THE GLENOID HEAD, TURON-TO-RSP CONVERSION SHELL AND THE POLYETHYLENE AND CLOSED.
Patient problems: Loss of Range of Motion; Pain
MAUDE report 6790814 ↗
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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