SMR Shoulder Humeral Head (CoCrMo) (REF 1322.09.541)Recalls & reported problems
Limacorporate SPA · Humeral Head (CoCrMo) - Dia.54mm H.18 · Class 2 · Implant
All models of SMR Shoulder (67)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033390068741), received between Mar 31, 2025 and Mar 31, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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
- Patient Device Interaction Problem1
Patient problems
- Muscle/Tendon Damage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 31, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
SHOULDER REVISION SURGERY OF A SMR STEMLESS ANATOMIC PROSTHESIS PERFORMED ON (B)(6)2025, DUE TO CUFF FAILURE. PATIENT CUFF FAILING AND RECURRENT DISLOCATIONS WERE REPORTED. THE SITE WAS APPROACHED THROUGH DELTO-PECTORAL INCISION. EXPOSURE WAS GOOD. THE SURGEON REMOVED THE FOLLOWING DEVICES: · SMR-FLATTENED HUMERAL HEAD D.54MM (PRODUCT CODE 1322.09.541, LOT #1604401 - STER. (B)(4)). · SMR STEMLESS - NEUTRAL ADAPTOR (PRODUCT CODE 1335.15.200, LOT #1815692 - STER. (B)(4)). · SMR STEMLESS - STEMLESS CORE #L (PRODUCT CODE 1355.14.238, LOT #1812164 - STER. (B)(4)). · LINER FOR METALBACK GLENOID LARGE (PRODUCT CODE 1377.50.030, LOT #18AT11W - STER. (B)(4)). THE GLENOID METALBACK WAS LEFT IN SITU. IT WAS REPORTED THAT THE SURGEON CONVERTED THE PROSTHESIS TO A STEMMED REVERSE AS HE FELT THAT THE RADIOGRAPHIC LYSIS AROUND THE CORE WOULD PROGRESS TO LOOSENING WITH STEMLESS. BUT THERE WERE NO ISSUES WITH THE CORE ITSELF. A 19MM HUMERAL STEM, A STANDARD HUMERAL BODY, TWO 9MM SPACERS, A LARGE LATERAL LINER AND A POLY GLENOSPHERE 44 WITH STANDARD CONNECTOR WERE USED. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2019. PATIENT IS A MALE, 57 YEARS OLD. IT IS REPORTED HE'S HEALTHY. EVENT HAPPENED IN AUSTRAL
Patient problems: Muscle/Tendon Damage
MAUDE report 21729221 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page