Anatomical Shoulder™ 01.04223.363Recalls & reported problems
Zimmer GmbH · Class 2 · Implant
All models of Anatomical Shoulder (33)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024481381), received between Sep 23, 2019 and Nov 10, 2021 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Most reported problems
Device problems
- Device Dislodged or Dislocated3
- Adverse Event Without Identified Device or Use Problem1
- Material Erosion1
Patient problems
- Joint Dislocation2
- Loss of Range of Motion1
- Metal Related Pathology1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 10, 2021Material Erosion; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Material Erosion; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS A REVISION DUE TO DISLOCATION AND METALLOSIS.
Patient problems: Loss of Range of Motion; Metal Related Pathology; Pain
MAUDE report 12786074 ↗InjuryOct 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE ITEM# 01.04223.363 LOT#2990537 HAS BEEN MOVED TO THE ASSOCIATED PRODUCT BECAUSE WAS NOT ACTIVELY INVOLVED IN THE EVENT. PLEASE DELETE THIS REPORT FROM YOUR DATABASE.
Patient problems: Joint Dislocation
MAUDE report 9165554 ↗InjurySep 23, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
Other PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED devices
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 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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