Anatomical Shoulder™ 01.04223.106Recalls & 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 00889024479401), received between Dec 21, 2020 and Nov 11, 2021 — classified as 3 injuries.
The most frequently reported specific device problem is “Fracture” (2 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
- Adverse Event Without Identified Device or Use Problem2
- Fracture2
- Insufficient Device Problem Information2
- Contamination /Decontamination Problem1
Patient problems
- Bacterial Infection1
- Deformity/ Disfigurement1
- Failure of Implant1
- Hematoma1
- Pain1
- Swelling1
- Swelling/ Edema1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 11, 2021Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information
PATIENT EXPERIENCED HEMATOMA, RADIOGRAPHIC NOTCHING, GENERAL MATERIAL FAILURE AND POSSIBLE SCREW BREAKAGE OF THE MOST CAUDAL SCREW, DEFINABLE BENDING OF THE MOST CAUDAL SCREW.
Patient problems: Deformity/ Disfigurement; Failure of Implant; Hematoma
MAUDE report 12795889 ↗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 WERE INTRA-OPERATIVE COMPLICATIONS CAUSED DUE TO IMPLANT FRACTURES AND THE SURGERY WAS DELAYED BY 1 HOUR.
Patient problems: Bacterial Infection
MAUDE report 11991803 ↗InjuryDec 21, 2020Contamination /Decontamination Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Contamination /Decontamination Problem; Insufficient Device Problem Information
INVESTIGATION RESULTS ARE NOW AVAILABLE.
Patient problems: Pain; Swelling; Swelling/ Edema; Unspecified Infection
MAUDE report 11045684 ↗
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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