SMR System 1322.09.540Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033390274319), received between Jan 26, 2026 and Jul 2, 2026 — classified as 2 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem

  A SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO A FAILED HEMI ANATOMIC IMPLANT. THE SURGEON REMOVED THE ANATOMIC HEAD AND ADAPTOR AND EXCISED THE SUPERIOR EDGE OF THE GLENOID. THE CTA HEAD WAS RE-IMPLANTED WITH THE ADAPTOR IN THE REVERSE POSITION TO ALLOW GREATER CONTACT WITH THE GLENOID RATHER THAN THE ACROMION. THE PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2025 AND CONSISTED OF A REVISION FOR A FAILED "REVERSE" TO HEMI ARTHROPLASTY, HOWEVER, THE ANATOMIC HEMI CONSTRUCT ENDED UP RESTING ON THE SUPERIOR EDGE OF THE GLENOID. THE SURGEON FOLLOWED THE STANDARD SURGICAL WORKFLOW FOR SHOULDER REVISION. THE EXPLANTED COMPONENTS INCLUDED: SMR HUMERAL HEAD Ø54 MM (PRODUCT CODE 1322.09.540, LOT 1921272, STER. N. 2000414). NEUTRAL ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.270, LOT 2503636, STER. N. 2500066). PATIENT IS FEMALE, 76 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 25688243 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO IRREPARABLE ROTATOR CUFF TEAR. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE INFORMATION ABOUT ORIGINAL IMPLANT. DURING REVISION THE SURGEON EXPLANTED THE PRE-EXISTING ANATOMIC COMPONENTS: - LINER FOR METAL BACK GLENOID SMALL (PART NUMBER 1377.50.020), - SMR FINNED HUMERAL BODY (PART NUMBER 1350.15.110), - SMR ECCENTRICAL ADAPTOR TAPER (PART NUMBER 1330.15.272), - SMR HUMERAL HEAD DIA54MM (PART NUMBER 1322.09.540), AND CONVERTED THE PROSTHESIS TO A REVERSE CONFIGURATION IMPLANTING A LATERALIZED +2MM CONNECTOR (PART NUMBER 1374.15.322), AN ECCENTRICAL GLENOSPHERE DIA40MM (PART NUMBER 1376.09.041), A REVERSE HUMERAL BODY (PART NUMBER 1352.15.010) AND REVERSE LINER +3MM DIA40 (PART NUMBER 1365.50.815). SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1968, WEIGHT 365LBS. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 24176355 ↗

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 · Terminated
  SMR 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 · Terminated
  SMR 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.