SMR Shoulder Humeral Head (CoCrMo) (REF 1321.09.441)Recalls & reported problems
Limacorporate SPA · Humeral Head (CoCrMo) - Dia.44mm H.14 · Class 2 · Implant
All models of SMR Shoulder (67)
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 08033390116268), received between May 29, 2025 and Mar 16, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
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
- Insufficient Device Problem Information1
- Patient Device Interaction Problem1
Patient problems
- Muscle/Tendon Damage1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 16, 2026Insufficient Device Problem Information
REVISION SURGERY HAS BEEN PERFORMED ON (B)(6) 2026 FOR UNKNOWN REASON. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE PRODUCT INFORMATION OF ORIGINAL IMPLANT. DURING REVISION SURGERY THE ORIGINAL HUMERAL HAED, ADAPTOR TAPER AND LINER FOR METAL BACK WERE REPLACED WITH NEW ONES (PN 1321.09.441, 1330.15.270, 1377.50.005 RESPECTIVELY). SURGERY WAS COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF BIRTH (B)(6)1960. EVENT OCCURRED IN THE UNITED STATES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24603380 ↗InjuryMay 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
SHOULDER REVISION SURGERY OF A SMR ANATOMIC TOTAL PROSTHESIS PERFORMED ON (B)(6) 2025, DUE TO CUFF FAILURE. ACCORDING TO THE INFORMATION RECEIVED, AFTER A DETERIORATION OF ROTATOR CUFF, IT WAS ADVISED THAT PATIENT CONVERT TO A REVERSE CONSTRUCT. THE FOLLOWING DEVICES WERE EXPLANTED: SMR HUMERAL HEAD D.44 H.14MM (PRODUCT CODE: 1321.09.441, LOT#: 2126295 - STER. 2200024). NEUTRAL ADAPTOR TAPER STANDARD (PRODUCT CODE: 1330.15.270, LOT#: 2014099 - STER. UNKNOWN). SMR TRAUMA HUMERAK BODY# LONG (PRODUCT CODE: 1350.15.020, LOT#: 1909580 - STER. 1900265). TT HYBRID CEMENTED GLENOID SMALL (PRODUCT CODE: 1379.59.110, LOT#: 2321146 - STER. 2300202). A 140° REVERSE BODY WAS IMPLANTED WITH A +3 LINER. THE REVISION BASEPLATE WAS IMPLANTED WITH A 36MM GLENOSPHERE. PRIMARY SURGERY TOOK PLACE ON (B)(6) 2023. PATIENT IS A FEMALE, 67 YEARS OLD. EVENT HAPPENED IN THE US.
Patient problems: Muscle/Tendon Damage
MAUDE report 22104992 ↗
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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