Anatomical Shoulder™ 01.04211.123Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024483309), received between Jun 23, 2020 and Jun 26, 2020 — classified as 4 injuries.
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 Problem3
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Pain2
- Unspecified Infection2
- Bacterial Infection1
- Inflammation1
- No Code Available1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 26, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PATIENT WAS IMPLANTED ON THE RIGHT SIDE EXPERIENCED INFECTION. A REVISION SURGERY HAS BEEN SCHEDULED FOR (B)(6) 2020.
Patient problems: Bacterial Infection; No Code Available; Unspecified Infection
MAUDE report 10200601 ↗InjuryJun 26, 2020Adverse Event Without Identified Device or Use Problem
InjuryJun 23, 2020Adverse Event Without Identified Device or Use Problem
InjuryJun 23, 2020Adverse Event Without Identified Device or Use Problem
PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND EXPERIENCED PAIN WHICH WAS SUSPECTED TO BE ATROPHY OF THE DELTOID. THE PATIENT UNDERWENT AN ARTHROSCOPIC PROCEDURE ON MAY 11, 2020 AND WAS FOUND TO HAVE BURSITIS AND A MIGRATED ANCHOR.
Patient problems: Inflammation; Pain
MAUDE report 10183268 ↗
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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