DJO SURGICAL 521-07-254Recalls & reported problems
Encore Medical, L.P. · AltiVate Anatomic, All-Poly Pegged Glenoid, Size 54, E-Plus · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00190446178392), received between Jul 13, 2017 and Dec 6, 2024 — classified as 16 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
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 Problem8
- Appropriate Device Problem Term/Code Not Available6
- Device Dislodged or Dislocated1
- Insufficient Device Problem Information1
- Naturally Worn1
Patient problems
- Failure of Implant4
- Implant Pain3
- Unspecified Infection3
- Joint Laxity2
- Medical device site infection2
- Insufficient Information1
- Joint Dislocation1
- No Code Available1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO MASSIVE CUFF TEAR AND POSSIBLE INFECTION.
Patient problems: Unspecified Infection
MAUDE report 20872935 ↗InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PAIN AND LOOSENING.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 17786477 ↗InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO AN INFECTION AND PAIN. CONVERTED FROM TOTAL TO REVERSE.
Patient problems: Medical device site infection; Pain
MAUDE report 15873828 ↗InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - INFECTED TOTAL SHOULDER OR SEPTIC PATIENT.
Patient problems: Medical device site infection
MAUDE report 15791728 ↗InjuryMay 7, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY DUE TO INSTABILITY.
Patient problems: Insufficient Information
MAUDE report 14317713 ↗InjuryFeb 2, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: DUE TO ROTATOR CUFF FAILURE.
Patient problems: Failure of Implant
MAUDE report 13426076 ↗InjuryJan 11, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD A FAILED CUFF CONVERTED FROM TOTAL TO A REVERSE.
Patient problems: Failure of Implant
MAUDE report 13231687 ↗InjuryDec 22, 2021Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - EARLY POST OPERATION INFECTION ALL IMPLANTS WERE REMOVED AND REPLACED.
Patient problems: Unspecified Infection
MAUDE report 13060322 ↗InjurySep 21, 2021Naturally Worn; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - NEED TO CONVERT THE TOTAL SHOULDER TO A REVERSE SHOULDER DUE EXCESSIVE GLENOID WEAR. HE USED BIOMET/ZIMMER TO CREATE A CUSTOM GLENOID IMPLANT AND DJO PROVIDED A CONVERSION SHELL AND POLY FOR THE HUMERUS.
Patient problems: Failure of Implant
MAUDE report 12505701 ↗InjuryJul 19, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WAS INFECTED; EVERYTHING WAS REMOVED AND A REVERSE PROSTHESIS WAS IMPLANTED.
Patient problems: Unspecified Infection
MAUDE report 12189285 ↗InjuryDec 10, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT PRESENTED ONE YEAR POST-OPERATION WITH FAILED SUBSCAP. SURGEON OPTED TO REVISE TO A REVERSE. ALL COMPONENTS WERE REMOVED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 9444557 ↗InjuryMar 21, 2019Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT DISLOCATING. THE SURGEON CONVERTED THE PATIENT TO A REVERSE SHOULDER SYSTEM.
Patient problems: Joint Dislocation
MAUDE report 8441577 ↗InjuryJul 13, 2017Insufficient Device Problem Information
REVISION SURGERY - DUE TO THE PATIENT TEARING THEIR SUBSCAP POST OP AND NEEDING TO BE REVISED TO A REVERSE TOTAL SHOULDER
Patient problems: No Code Available
MAUDE report 6712032 ↗
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-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
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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