Anatomical Shoulder™ Domelock® 01.04212.465 (UDI 00889024274884)Recalls & reported problems
Zimmer GmbH · Humeral Head Ø46-16 · Class 2 · Implant
All models of Anatomical Shoulder Domelock (10)
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 00889024274884), received between Jun 15, 2023 and Feb 18, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (1 report).
1 other recall cover devices cleared under the same FDA submission (K142403); they may or may not involve this specific model.
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
- Physical Resistance/Sticking1
Patient problems
- Pain2
- Extraskeletal ossification1
- Loss of Range of Motion1
- Muscle/Tendon Damage1
- Osteolysis1
- Tissue Breakdown1
Recent adverse event reports
The 3 most recent of 3 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 21392502 ↗InjuryDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED ACCORDING TO A CLINICAL STUDY THAT THE PATIENT WAS IMPLANTED WITH AN ANATOMIC TOTAL SHOULDER IMPLANT ON THE RIGHT SIDE. A CONVERSION TO A REVERSE SHOULDER ARTHROPLASTY HAS BEEN PERFORMED APPROXIMATELY 3 AND A HALF YEARS POST IMPLANTATION DUE TO A ROTATOR CUFF INSUFFICIENCY. DILIGENCE IS COMPLETED AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Tissue Breakdown
MAUDE report 18397566 ↗InjuryJun 15, 2023Physical Resistance/Sticking; Physical Resistance/Sticking
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Loss of Range of Motion; Muscle/Tendon Damage; Pain
MAUDE report 17133940 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K142403. One submission often covers many models, so check the product and lot details in each record.
- Z-2003-2016 · May 17, 2016 · TerminatedDome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0. The Dome Centric connects the Humeral Stem to the Humeral Head and allows setting an i
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 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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