Anatomical Shoulder™ 01.04223.406Recalls & 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
- 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 00889024481428), received between Aug 7, 2019 and Jun 14, 2021 — classified as 5 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 Dislocated4
- Adverse Event Without Identified Device or Use Problem1
- Disconnection1
- Fracture1
- Naturally Worn1
Patient problems
- Joint Dislocation4
- Bacterial Infection1
- Failure of Implant1
- Insufficient Information1
- Metal Related Pathology1
- Pain1
- Reaction1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJun 14, 2021Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT A REVISION SURGERY DUE TO PERIPROSTHETIC INFECTION. THERE WAS INTRA-OPERATIVE COMPLICATION DUE TO IMPLANT FRACTURE DURING THE REVISION SURGERY LEADING TO A SURGICAL DELAY OF 1 HOUR.
Patient problems: Bacterial Infection
MAUDE report 11991784 ↗InjuryFeb 23, 2021Disconnection; Device Dislodged or Dislocated; Disconnection; Device Dislodged or Dislocated
INVESTIGATION HAS BEEN COMPLETED.
Patient problems: Insufficient Information; Joint Dislocation; Metal Related Pathology
MAUDE report 11364022 ↗InjurySep 24, 2019Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn
INVESTIGATION RESULTS ARE NOW AVALIABLE.
Patient problems: Failure of Implant; Joint Dislocation; Pain; Reaction
MAUDE report 9108703 ↗InjuryAug 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
InjuryAug 7, 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.
How reports and recalls are matched · Editorial policy · Report an error on this page