SMR Shoulder Humeral Head (REF 1322.09.540)Recalls & reported problems
Limacorporate SPA · Humeral heads (CoCrMo) dia.54mm · 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 08033390001434), received between Mar 3, 2025 and Mar 3, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K100858); 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
- Break1
Patient problems
- Metal Related Pathology1
- 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 3, 2025Break; Break
SHOULDER REVISION SURGERY OF A SMR ANATOMIC TOTAL PROSTHESIS PERFORMED ON (B)(6) 2025, DUE TO CUFF FAILURE, LEADING TO ECCENTRIC LOADING ON THE POLY LINER AND CAUSING WEAR OF THE PROSTHESIS. THE BREAKAGE OF METAL BACK WAS REPORTED BUT PRODUCT INFORMATION IS NOT AVAILABLE. ACCORDING TO THE RECEIVED INFORMATION, THE METALLOSIS WAS EVIDENT. THE FOLLOWING COMPONENTS WERE EXPLANTED: · SMR HUMERAL HEAD Ø54 MM (PRODUCT CODE 1322.09.540, LOT #0303179 - STER. UNKNOWN) · NEUTRAL ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.270, LOT #0400500 - STER. UNKNOWN) · ANATOMIC HUMERAL BODY (PRODUCT CODE AND LOT # UNKNOWN) · METAL BACK (PRODUCT CODE AND LOT # UNKNOWN) · POLY LINER (PRODUCT CODE AND LOT # UNKNOWN) · 2 BONE SCREWS (PRODUCT CODES AND LOT #S UNKNOWN) THE EXPLANTED COMPONENTS WERE REPLACED WITH A NEW HUMERAL BODY AND A CTA HUMERAL HEAD. THE PRIMARY SURGERY TOOK PLACE 15 YEARS AGO, BUT THE PRECISE DATE IS KNOWN. PATIENT IS A MALE. IT IS REPORTED HE PERFORMS MODERATE ACTIVITY LEVEL. UP TO DATE, NO FURTHER INFORMATION IS AVAILABLE. EVENT HAPPENED IN AUSTRALIA.
Patient problems: Metal Related Pathology; Muscle/Tendon Damage
MAUDE report 21502847 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K100858. One submission often covers many models, so check the product and lot details in each record.
- Z-2539-2015 · Aug 14, 2015 · TerminatedSMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral
- Z-2540-2015 · Aug 14, 2015 · TerminatedSMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery.
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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