Anatomical Shoulder™ 01.04223.042Recalls & reported problems
Zimmer GmbH · Class 2
All models of Anatomical Shoulder (33)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024483057), received between Feb 5, 2020 and Apr 18, 2024 — classified as 8 injuries.
The most frequently reported specific device problem is “Fracture” (3 reports).
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 Problem3
- Fracture3
- Patient Device Interaction Problem2
- Appropriate Device Problem Term/Code Not Available1
- Biocompatibility1
- Device Dislodged or Dislocated1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Material Integrity Problem1
Patient problems
- Failure of Implant2
- Insufficient Information2
- Pain2
- Unspecified Infection2
- Cognitive Changes1
- Implant Pain1
- Inflammation1
- Joint Dislocation1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 18418441 ↗InjurySep 12, 2023Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A SHOULDER REVISION DUE TO DISLOCATIONS. PATIENT REQUIRES CUSTOM MADE IMPLANT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Joint Dislocation; No Clinical Signs, Symptoms or Conditions
MAUDE report 17727931 ↗InjuryMar 15, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Unspecified Infection
MAUDE report 13769460 ↗InjuryAug 10, 2021Fracture; Fracture
NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 12299894 ↗InjuryApr 20, 2021Fracture; Material Integrity Problem; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Material Integrity Problem; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth
NO CHANGE TO PREVIOUSLY REPORTED EVENT.
Patient problems: Failure of Implant; Pain
MAUDE report 11691716 ↗InjuryDec 17, 2020Fracture; Biocompatibility; Fracture; Biocompatibility
NO CHANGE TO PREVIOUSLY REPORTED EVENT.
Patient problems: Implant Pain; Inflammation; Pain; Unspecified Infection
MAUDE report 11028129 ↗InjuryFeb 5, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PATIENT WAS IMPLANTED ON THE LEFT SIDE AND REVISION SURGERY HAS BEEN PLANNED FOR RADIOLUCENCY.
Patient problems: No Code Available
MAUDE report 9671006 ↗
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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