Anatomical Shoulder™ 01.04223.033Recalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024483033), received between May 13, 2019 and Dec 29, 2023 — classified as 5 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information3
- Adverse Event Without Identified Device or Use Problem2
- Appropriate Device Problem Term/Code Not Available1
- Contamination /Decontamination Problem1
- Patient-Device Incompatibility1
Patient problems
- Unspecified Infection4
- Pain2
- Bacterial Infection1
- Insufficient Information1
- Swelling/ Edema1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
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 18418438 ↗InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem
NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.
Patient problems: Bacterial Infection; Pain; Unspecified Infection
MAUDE report 12007871 ↗InjuryDec 22, 2020Contamination /Decontamination Problem; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Contamination /Decontamination Problem; Insufficient Device Problem Information
INVESTIGATION RESULTS ARE NOW AVAILABLE.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 11055987 ↗InjuryMay 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO POSSIBLE PROSTHETIC JOINT INFECTION. A SUBSEQUENT SURGERY ON THE (B)(6) WAS DUE TO THE IRRIGATION OF THE RIGHT SHOULDER AND THE DEBRIDEMENT OF AN INFECTED RTSA.
Patient problems: Unspecified Infection
MAUDE report 8603586 ↗InjuryMay 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO POSSIBLE PROSTHETIC JOINT INFECTION. A SUBSEQUENT SURGERY ON THE (B)(6) WAS DUE TO THE IRRIGATION OF THE RIGHT SHOULDER AND THE DEBRIDEMENT OF AN INFECTED RTSA.
Patient problems: Unspecified Infection
MAUDE report 8603566 ↗
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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