SMR Shoulder Humeral Head (CoCrMo) (REF 1322.09.501)Recalls & reported problems
Limacorporate SPA · Humeral Head (CoCrMo) - Dia.50mm H.16 · 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 08033390068727), received between May 26, 2026 and May 26, 2026 — classified as 1 injury.
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
- No Apparent Adverse Event1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 26, 2026No Apparent Adverse Event
REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO UNKNOWN REASON. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2021 WHEN FOLLOWING ANATOMIC CONFIGURATION OF SMR SYSTEM WAS IMPLANTED: - FINNED STEM DIA17MM L80 (PN 1304.15.270). - FINNED HUMERAL BODY (PN 1350.15.110, LOT 2110797, STERILIZATION (B)(4)). - ADAPTOR TAPER ECCENTRICAL 2MM (PN 1330.15.272, LOT 2108248, STERILIZATION (B)(4)). - HUMERAL HEAD DIA50 H16 (PN 1322.09.501, LOT 2010990, STERILIZATION (B)(4)). - METAL BACK GLENOID STD (PN 1375.21.010). - LINER FOR METAL BACK STD (PN 1377.50.010, LOT 20AT5KW, STERILIZATION (B)(4)). DURING REVISION THE PRE-EXISTING FINNED HUMERLA BODY, ADAPTOR TAPER, HUMERAL HEAD AND LINER FOR METAL BACK WERE REMOVED AND THE CONSTRUCT WAS CONVERTED TO A REVERSE CONFIGURATION IMPLANTING: - REVERSE HUMERAL BODY (PN 1352.15.010). - REVERSE LINER +6MM (PN 1360.50.820). - CONNECTOR + SCREW SMALL STD (PN 1374.15.310). - GLENOSPHERE ECCENTRICAL DIA36 (PN 1376.09.031). SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1958. THE EVENT OCCURRED IN THE UNITED STATES.
Patient problems: Insufficient Information
MAUDE report 25275483 ↗
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.
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