SMR Shoulder Humeral Body (REF 1350.15.030)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033390002028), received between May 9, 2025 and May 9, 2025 — classified as 1 injury.

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SHOULDER REVISION SURGERY OF A SMR ANATOMIC HEMI PROSTHESIS PERFORMED ON (B)(6)2025, DUE TO POOR BONE QUALITY. THIS IS A SECOND STAGE REVISION SURGERY: IT WAS REPORTED THAT THE PATIENT HAD A PRIOR ANATOMIC SHOULDER WITH A CEMENTED 3-PEGGED POLY GLENOID (PRODUCT CODE AND LOT # UNKNOWN). THE PATIENT WAS REVISED AND THE CEMENTED POLY GLENOID WAS REMOVED (DATE OF THE SURGERY UNKNOWN). THE GLENOID WAS PACKED WITH A BONE GRAFT AND LEFT TO HEAL FOR THE SECOND STAGE REVISION. AT THE TIME, AN ANATOMIC HUMERAL BODY AND A HUMERAL HEAD WERE IMPLANTED, AND THE PATIENT WAS LEFT WITH THE HEMI PROSTHESIS. UPON INSPECTION OF THE GLENOID ON THE SURGERY OF (B)(6) 2025, THE BONE QUALITY WAS DEEMED TOO POOR TO PROCEED TO A REVERSE BASEPLATE. THE FOLLOWING DEVICES WERE EXPLANTED: · SMR TRAUMA HUMERAL BODY # SHORT (PRODUCT CODE 1350.15.030, LOT #1601336 - STER. (B)(4)). · SMR HUMERAL HEAD D.44 H.14MM (PRODUCT CODE 1321.09.441, LOT #2014027 - STER. (B)(4)). · NEUTRAL ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.270, LOT #2014099 - STER. (B)(4)). THE SAME SIZE COMPONENTS WERE PUT BACK IN AND THE PATIENT WILL HAVE A HEMI FOR THE FORESEEABLE FUTURE. PATIENT IS A FEMALE, 81 YEARS OLD. POOR BONE QUALITY REPORT

  Patient problems: Inadequate Osseointegration

  MAUDE report 21993924 ↗

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.