DJO SURGICAL 521-07-250Recalls & reported problems
Encore Medical, L.P. · AltiVate Anatomic, All-Poly Pegged Glenoid, Size 50, E-Plus · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Surgical AltiVate shoulder implant is a metal humeral prosthesis used in shoulder replacement surgery. The 31 reports describe pain, loosening of the implant, joint instability and infection, with several patients needing revision surgery; 31 injuries and no deaths were reported. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 30
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00190446178385), received between Mar 20, 2019 and Mar 2, 2026 — classified as 30 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 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
- Adverse Event Without Identified Device or Use Problem18
- Appropriate Device Problem Term/Code Not Available5
- Loosening of Implant Not Related to Bone-Ingrowth4
- Unstable3
- Insufficient Device Problem Information1
- Patient Device Interaction Problem1
- Unintended System Motion1
Patient problems
- Unspecified Infection6
- Joint Laxity5
- Failure of Implant3
- Implant Pain3
- Insufficient Information3
- No Known Impact Or Consequence To Patient3
- Medical device site infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
InjuryMar 2, 2026Unintended System Motion
REVISION SURGERY - DUE TO SOME PAIN AND INFLAMMATION, THOUGHT TO BE INFECTED, LACK OF MOVEMENTS.
Patient problems: Loss of Range of Motion; Unspecified Infection
MAUDE report 24477791 ↗InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
REVISION SURGERY - DUE TO IMPLANT FAILURE
Patient problems: Failure of Implant
MAUDE report 24000011 ↗InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT WAS COMPLAINING OF PAIN.
Patient problems: Implant Pain
MAUDE report 19924766 ↗InjuryMay 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO ROTATOR CUFF TEAR AND SERIOUS RISK TO PATIENT.
Patient problems: Insufficient Information; Limb Fracture
MAUDE report 18727832 ↗InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 20, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 4, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMar 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT HAD FAILED DJO ANATOMIC. SURGEON EXPLANTED ALL IMPLANTS AND PUT IN A DJO REVERSE SHOULDER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16015381 ↗InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Medical device site infection
MAUDE report 15820719 ↗InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO AN INFECTION, THE IMPLANTS WERE REMOVED AND ANOTHER DISTRIBUTOR SPACER WAS PUT IN.
Patient problems: Medical device site infection
MAUDE report 15498086 ↗InjurySep 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT WAS EXPERIENCING RIGHT SHOULDER PAIN. POLY WEAR POSTERIOR GLENOID.
Patient problems: Pain
MAUDE report 15489328 ↗InjuryAug 17, 2022Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - THE PATIENT'S STEM WAS LOOSE DUE TO POTENTIAL INFECTION.
Patient problems: Unspecified Infection
MAUDE report 15243390 ↗InjuryMay 6, 2022Unstable
REVISION SURGERY DUE TO INSTABILITY AND INFECTION.
Patient problems: Unspecified Infection
MAUDE report 14307062 ↗InjuryApr 22, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY PATIENT DISPLAYED WITH A BAD CUFF AND INSTABILITY POST PRIMARY SURGERY. PATIENT NEEDED CONVERSION TO A REVERSE SHOULDER PROSTHESIS TO RESTORE FUNCTION. SHOULDER FUNCTION AND STABILITY WERE RESTORED USING IMPLANTS.
Patient problems: Insufficient Information
MAUDE report 14188550 ↗InjuryJan 4, 2022Appropriate Device Problem Term/Code Not Available
InjurySep 9, 2021Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY: GLENOID WAS LOOSE CAUSING NEED TO REMOVE ALTIVATE ANATOMIC SHOULDER AND IMPLANT REVERSE SHOULDER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12448914 ↗InjuryMar 30, 2021Insufficient Device Problem Information
REVISION SURGERY - PATIENT PRESENTED WITH A FAILED POST OPERATIVE TOTAL SHOULDER. SURGEON DETERMINED THAT A REVERSE SHOULDER WAS THE BEST OPTION. ALL COMPONENTS BEING REMOVED.
Patient problems: Failure of Implant
MAUDE report 11590539 ↗
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-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-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-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-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
- 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
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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