Anatomical Shoulder™ 01.04201.123Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024484924), received between Jun 9, 2023 and Feb 18, 2025 — classified as 2 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Pain2
- Extraskeletal ossification1
- Loss of Range of Motion1
- Osteolysis1
- Scar Tissue1
- Subluxation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Extraskeletal ossification; Osteolysis; Pain
MAUDE report 21396169 ↗InjuryJun 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH A CLINICAL STUDY THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY APPROXIMATELY SIX (6) YEARS AGO. APPROXIMATELY SEVEN (7) MONTHS AFTER IMPLANTATION, THE PATIENT HAD DEVELOPED PAIN. ABOUT ONE AND HALF (1,5) YEARS LATER, INFECTION WAS RULED OUT AND COMPONENTS WERE FOUND TO BE STABLE, HOWEVER EXTENSIVE DEBRIDEMENT OF INTRA-AND EXTRA-ARTICULAR SCAR TISSUE WAS REQUIRED. THE HEAD WAS NOTED TO BE SLIGHTLY OVERSTUFFED AND SOMEWHAT SUBLUXATED VENTRALLY. AS OF THE FIVE (5) YEAR STUDY FOLLOW-UP VISIT, THE PATIENT IS SATISFIED AND ABLE TO COMPLETE THE MAJORITY OF DAILY ACTIVITIES WITH MINIMAL PAIN. THERE HAVE BEEN NO OTHER ADVERSE EVENTS OR COMPLICATIONS REPORTED. THE ORIGINAL STUDY COMPONENTS REMAIN IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Loss of Range of Motion; Pain; Scar Tissue; Subluxation
MAUDE report 17097482 ↗
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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