DJO SURGICAL 521-07-246Recalls & reported problems
Encore Medical, L.P. · AltiVate Anatomic, All-Poly Pegged Glenoid, Size 46, E-Plus · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO AltiVate shoulder glenoid implant is a cemented shoulder prosthesis. The 41 reports mostly describe revision surgery involving loosening, instability, separation, implant failure, pain, or infection; there were 41 injuries and no deaths. No recalls name this device. Reports increased from 2 in the previous 12 months to 4 in the latest 12 months.
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
- 42
- Deaths reported
- 0
- Injuries reported
- 42
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00190446178378), received between Aug 10, 2018 and Sep 25, 2026 — classified as 42 injuries.
The most frequently reported specific device problem is “Unstable” (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 Problem22
- Appropriate Device Problem Term/Code Not Available9
- Unstable4
- Device Dislodged or Dislocated3
- Loosening of Implant Not Related to Bone-Ingrowth2
- Therapeutic or Diagnostic Output Failure2
- Break1
- Detachment of Device or Device Component1
Patient problems
- Joint Laxity10
- Insufficient Information8
- Implant Pain5
- No Code Available5
- Failure of Implant3
- Unspecified Infection3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Pain2
Recent adverse event reports
The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50892499 ↗InjuryMay 19, 2026Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY DUE TO PATIENT'S GLENOID FAILED. NEEDED TO BE REVISED TO REVERSE.
Patient problems: Incompetent Cervix
MAUDE report 25225295 ↗InjuryNov 26, 2025Unstable; Unstable
InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
InjuryFeb 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO PAIN & LOOSENING.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 21440516 ↗InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO SIGNIFICANT ADVERSE EVENT.
Patient problems: Insufficient Information
MAUDE report 20909610 ↗InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT PRESENTED PAIN IN RIGHT SHOULDER.
Patient problems: Implant Pain
MAUDE report 20376699 ↗InjuryJun 26, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO REVISED FROM ANATOMIC TO REVERSE DUE TO SUBCAP AND SIGNIFICANT ADVERSE EVENT REPORTED
Patient problems: Insufficient Information
MAUDE report 19621233 ↗InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - CONVERTED TO REVERSE TOTAL SHOULDER DUE TO SUBSCAPULARIS FAILURE..
Patient problems: Joint Laxity
MAUDE report 18323653 ↗InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 5, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - ALL ITEMS WERE TAKEN OUT TO MAKE A REVERSE.
Patient problems: Insufficient Information
MAUDE report 16710688 ↗InjuryOct 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - ANATOMIC CONVERTED TO REVERSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15693814 ↗InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO SUBSCAP FAILURE.
Patient problems: Muscle/Tendon Damage
MAUDE report 15564032 ↗InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 20, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT DEVELOPED INSTABILITY OF THE SHOULD JOINT AND ROTATOR CUFF ARTHROPATHY. THEREFORE NEEDED TO BE CONVERTED TO A REVERSE SHOULDER. ALL IMPLANTS WERE REMOVED AND THE REVERSE WAS IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 14463170 ↗InjuryApr 11, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: ALL IMPLANTS FROM ORIGINAL SURGERY REMOVED DUE TO ROTATOR CUP TEAR.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14074336 ↗
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-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-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-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, semi-constrained, metal/polymer + additive, cemented devices
- Comprehensive Reverse Shoulder 115310Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death99 reports
- INHANCE 5120-00-110Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented75 reports
- Comprehensive® Reverse Shoulder XL-115364Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall7 reports
- Comprehensive® Reverse Shoulder XL-115366Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall4 reports
- Comprehensive® Reverse Shoulder 180550Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 deaths43 reports
- Comprehensive® Reverse Shoulder 180551Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented42 reports
- Comprehensive® 110031399Zimmer, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death36 reports
- Comprehensive® Reverse Shoulder 115396Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented35 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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