Anatomical Shoulder™ 01.04211.093Recalls & 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 00889024484894), received between Feb 3, 2021 and May 18, 2021 — classified as 3 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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
- Patient Device Interaction Problem2
- Appropriate Device Problem Term/Code Not Available1
- Device Damaged by Another Device1
Patient problems
- Muscle/Tendon Damage2
- Insufficient Information1
- Loss of Range of Motion1
- Muscle Weakness/Atrophy1
- Pain1
- Rupture1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED ON THE LEFT SIDE AND STARTED EXPERIENCING PAIN WHICH WAS TREATED BY ARTHROSCOPIC ARTHROLYSIS SURGERY. THE POSSIBILITY OF FROZEN SHOULDER OR ADHESIVE CAPSULITIES IS YET TO BE CONFIRMED. THE EVENT IS INDICATED AS AN SAE MILD IN INTENSITY. THIS EVENT IS PART OF A DOMELOCK STUDY - ID (B)(4) AT THE (B)(6) HOSPITAL.
Patient problems: Pain
MAUDE report 11840459 ↗InjuryMar 23, 2021Device Damaged by Another Device; Patient Device Interaction Problem; Device Damaged by Another Device; Patient Device Interaction Problem
NO CHANGE TO PREVIOUSLY REPORTED EVENT.
Patient problems: Insufficient Information; Loss of Range of Motion; Muscle Weakness/Atrophy; Muscle/Tendon Damage
MAUDE report 11555094 ↗InjuryFeb 3, 2021Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available
PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT A REVISION SURGERY DUE TO COMPLETE RUPTURE OF THE SUBSCAPULAR TENDON MEASURING MORE THAN 2 CM.
Patient problems: Muscle/Tendon Damage; Rupture
MAUDE report 11271123 ↗
Other PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 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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