DJO SURGICAL 521-07-238Recalls & reported problems
Encore Medical, L.P. · AltiVate Anatomic, All-Poly Pegged Glenoid, Size 38, E-Plus · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a DJO Surgical shoulder implant, the AltiVate Anatomic all-polyethylene pegged glenoid component used in total shoulder replacement. The 30 reports mostly describe a loose glenoid part and instability of the shoulder joint, often with pain, and in some cases a suspected infection, leading patients to have revision surgery to remove, convert, or replace the implant. No deaths were reported; all 30 reports involved injuries. No recalls name 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 00190446178354), received between Dec 28, 2017 and Jun 29, 2026 — classified as 30 injuries.
The most frequently reported specific device problem is “Unstable” (5 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 Problem17
- Appropriate Device Problem Term/Code Not Available5
- Unstable5
- Loose or Intermittent Connection2
- Patient Device Interaction Problem2
- Device Operates Differently Than Expected1
- Insufficient Device Problem Information1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Joint Laxity10
- Insufficient Information4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- No Code Available3
- Unspecified Infection3
- Failure of Implant2
- Implant Pain2
- Pain2
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
InjuryJun 29, 2026Patient Device Interaction Problem
REVISION SURGERY DUE TO THE PATIENT HAD LOOSENING OF THE GLENOID IMPLANT AND SUSPECTED INFECTION.
Patient problems: Joint Laxity; Unspecified Infection
MAUDE report 25650348 ↗InjuryMay 29, 2026Unstable
InjuryApr 24, 2026Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY DUE TO PATIENT WITH FAILED ALTIVATE ANATOMIC SHOULDER WITH LOOSE GLENOID. REMOVED GLENOID. REVISED WITH AUGMENTED BASEPLATE AND GLENOSPHERE WITH REVISION CONVERSION ALTIVATE RSP SHELL AND POLY
Patient problems: Joint Laxity
MAUDE report 24990893 ↗InjuryFeb 25, 2026Unstable; Adverse Event Without Identified Device or Use Problem
PATIENT PRESENTED WITH SHOULDER INSTABILITY. UPON X-RAY IT WAS DETERMINED THAT GLENOID COMPONENT WAS LOOSE. REVISION SURGERY WAS SCHEDULED TO CONVERT TO A REVERSE SHOULDER.
Patient problems: Joint Laxity
MAUDE report 24445824 ↗InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
PATIENT PRESENTED MORE THAN 6 YEARS POST OP WITH COMPLAINTS OF PAIN. SURGEON OPTED TO REVISE AND REMOVE ALL COMPONENTS.
Patient problems: Pain
MAUDE report 23796738 ↗InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 12, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PAIN AND INSTABILITY.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 22007086 ↗InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 22, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO ANATOMIC TOTAL SHOULDER ARTHROPLASTY EXPLANTED AND REPLACED WITH REVERSE TOTAL SHOULDER ARTHROPLASTY
Patient problems: Insufficient Information
MAUDE report 20511346 ↗InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - MDR - WEARING/REQUIRED INTERVENTION TO PREVENT IMPAIRMENT/DAMAGE (REVISION)-PATIENT'S GLENOID HAD WORN DOWN, NEEDED TO BE SWITCHED TO REVERSE.
Patient problems: Failure of Implant
MAUDE report 18288866 ↗InjuryOct 25, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT WAS EXPERIENCING DISLOCATION.
Patient problems: Joint Dislocation
MAUDE report 16153489 ↗InjurySep 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT PRESENTED TO SURGEON OFFICE WITH SHOULDER PAIN AND A LOSS OF FUNCTION. IT WAS DETERMINED THAT THE SUBSCAP HAD RUPTURED AND REVISION SURGERY TO A REVERSE SHOULDER WAS NEEDED.
Patient problems: Pain
MAUDE report 15412292 ↗InjuryApr 12, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - SURGEON TOOK EVERYTHING OUT AND CONVERTED TO A RESERVE.
Patient problems: Insufficient Information
MAUDE report 14086066 ↗InjuryApr 11, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD AN ACCIDENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14074329 ↗InjuryFeb 2, 2022Output Problem
REVISION SURGERY: PATIENT TORE HER CUFF. SURGEON NEEDED TO REMOVE AND DO A REVERSE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13426069 ↗InjuryNov 11, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO GLENOID LOOSENING.
Patient problems: Insufficient Information
MAUDE report 12798737 ↗InjuryNov 7, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT TORE HER ROTATOR CUFF BEYOND REPAIR. SURGEON REVISED HER TO A REVERSE TOTAL SHOULDER.
Patient problems: Unspecified Tissue Injury
MAUDE report 12759046 ↗InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - CONVERTED TO REVERSE SHOULDER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11454831 ↗InjuryMay 28, 2020Therapeutic or Diagnostic Output Failure
REVISION SURGERY - DUE TO PATIENT REVISED FROM ANATOMIC TO REVERSE DUE TO FAILED ROTATOR CUFF.
Patient problems: No Code Available
MAUDE report 10097827 ↗InjuryFeb 27, 2020Appropriate Device Problem Term/Code Not Available
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-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-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-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-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
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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