DJO SURGICAL 804-07-461Recalls & reported problems
Encore Medical, L.P. · AltiVate Anatomic, Pegged Glenoid Trial, Size 46 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00190446284376), received between Apr 30, 2021 and Mar 13, 2026 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
6 other recalls cover devices cleared under the same FDA submission (K162024); 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
- Detachment of Device or Device Component2
- Break1
- Device Handling Problem1
- No Apparent Adverse Event1
Patient problems
- Foreign Body In Patient3
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2026Detachment of Device or Device Component
INSTRUMENT FAILURE - GLENOID BASEPLATE DRIVER SNAPPED OFF IN THE BASEPLATE, DELAT IN SURGERY, BROKEN FRAGMNENTED PIECES LEFT IN THE PATIET.
Patient problems: Foreign Body In Patient
MAUDE report 24596604 ↗MalfunctionFeb 18, 2026Detachment of Device or Device Component
INSTRUMENT FAILURE - WHEN TRIALING THE 46 GLENOID, ONE OF THE PERIPHERAL PEGS BROKE OFF.
Patient problems: Foreign Body In Patient
MAUDE report 24384446 ↗InjuryFeb 28, 2023No Apparent Adverse Event; No Apparent Adverse Event
INTRUMENT FAILURE - PIECE OF BROKEN INSTRUMENT WAS LEFT IN THE PATIENT, THE DR LEFT IT IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 16456782 ↗MalfunctionNov 30, 2022Device Handling Problem; Device Handling Problem
INSTRUMENT FAILURE - WHILE DOING A ANATOMIC TOTAL SHOULDER, SURGEON WAS TRIALING THE 46 (BLUE) GLENOID TRIAL. ONE OF THE SIDE PEGS BROKE OFF. SURGEON REMOVED THE TRIAL AND ELECTED TO LEAVE THE BROKEN PIECE IN THE GLENOID.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15888475 ↗MalfunctionApr 30, 2021Break
INSTRUMENT FAILURE - DURING A PRIMARY ANATOMIC SHOULDER ARTHROPLASTY, THIS ITEM BROKE DURING USE. THE CENTER PEG BROKE OFF INTO THE PATIENT WHILE THE SURGEON WAS ATTEMPTING TO REMOVE THE BLUE SIZE 46 TRIAL GLENOID COMPONENT. AFTER TRYING TO REMOVE THE BROKEN PEG, THE SURGEON SUCCESSFULLY DID SO AND PROCEEDED WITH THE CASE AS PLANNED. NO PIECES REMAINED IN THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 11758086 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K162024. One submission often covers many models, so check the product and lot details in each record.
- Z-2331-2021 · Jun 28, 2021 · Open, ClassifiedAltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-12-000, 4. Part # 520-14-000, 5. Part # 520-16
- Z-1259-2018 · Jan 29, 2018 · CompletedAltivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as
- Z-1258-2018 · Jan 29, 2018 · CompletedAltivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as
- Z-1257-2018 · Jan 29, 2018 · CompletedAltivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as
- Z-1256-2018 · Jan 29, 2018 · CompletedAltivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as
- Z-1260-2018 · Jan 29, 2018 · CompletedAltivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated
Other PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 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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