Anatomical Shoulder™ 01.04223.030Recalls & 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
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024483026), received between Feb 20, 2020 and Sep 2, 2025 — classified as 6 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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
- Loosening of Implant Not Related to Bone-Ingrowth3
- Adverse Event Without Identified Device or Use Problem2
- Fracture2
- Device Dislodged or Dislocated1
- Insufficient Device Problem Information1
- Mechanical Problem1
- Patient Device Interaction Problem1
Patient problems
- Bone Fracture(s)2
- Insufficient Information2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Bacterial Infection1
- Failure of Implant1
- Fall1
- Implant Pain1
- Inadequate Osseointegration1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 11, 2021Fracture; Device Dislodged or Dislocated; Patient Device Interaction Problem; Fracture; Device Dislodged or Dislocated; Patient Device Interaction Problem
PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE AND POST-IMPLANTATION EXPERIENCED LOOSENING OF THE GLENOID, LEFT SHOULDER, GENERAL FAILURE OF THE MATERIAL AND RECURRENT PAIN ON THE LEFT SIDE ALONG WITH ACUTE SUBACROMIAL BURSITIS AND RIGHT RIB FRACTURE, VD. FOR SCREW BREAKAGE AND LOOSENING OF THE GLENOID COMPONENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bone Fracture(s); Failure of Implant; Implant Pain; Pain
MAUDE report 12793531 ↗InjuryAug 25, 2021Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth
INVESTIGATION RESULTS ARE NOW AVAILABLE.
Patient problems: Inadequate Osseointegration; Insufficient Information
MAUDE report 12364402 ↗InjuryFeb 23, 2021Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth
NO CHANGE TO PREVIOUSLY REPORTED EVENT.
Patient problems: Fall; Insufficient Information
MAUDE report 11364017 ↗InjuryJul 29, 2020Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth
INVESTIGATION HAS BEEN COMPLETED.
Patient problems: Bacterial Infection; Unspecified Infection
MAUDE report 10338212 ↗InjuryFeb 20, 2020Fracture; Fracture
PATIENT WAS IMPLANTED ON THE UNKNOWN SIDE AND UNDERWENT REVISION SURGERY DUE TO IMPLANT FRACTURE. THE LOWER SIDE OF THE IMPLANT, FIXED TO THE BASEPLATE WAS FRACTURED CAUSING THE GLENOID HEAD TO TILT UPWARDS.
Patient problems: No Information
MAUDE report 9731864 ↗
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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