SMR System 1322.09.500Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033390274272), received between Nov 10, 2025 and Jan 28, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.

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.

• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO CUFF FAILURE. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE PRODUCT INFORMATION OF ORIGINAL IMPLANT. DURING REVISION THE SURGEON REMOVED THE PRE-EXISTING ANATOMIC COMPONENTS SMR TRAUMA HUM. BODY # MEDIUM (PART NUMBER 1350.15.010), SMR ECC.ADAPTOR TAPER STD +2MM (PART NUMBER 1330.15.272) AND SMR HUMERAL HEAD Ø50 MM (PART NUMBER 1322.09.500) TO CONVERT THE PROSTHESIS TO A REVERSE CONFIGURATION WITH FOLLOWING COMPONENTS: - GLENOSPHERE DIA36MM (PN (B)(4)), - LATERALIZED +2MM CONNECTOR SMALL/STD (PN 1374.15.322) - 140° REVERSE HUMERAL BODY SHORT (PN 1352.15.015) - REVERSE LINER +6MM (PN (B)(4)). THE SURGERY HAS BEEN COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 2025. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 24201310 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  REVISION SURGERY PERFORMED DUE TO ROTATOR CUFF PATHOLOGY FOLLOWING AN SMR TOTAL SHOULDER ARTHROPLASTY. ACCORDING TO THE AVAILABLE INFORMATION, INTER-OPERATIVELY THE TT PEG ON THE GLENOID SIDE WAS SOLID AND THE SURGEON WAS ABLE TO CONVERT TO A REVISION TT BASEPLATE TO ACCOMMODATE A GLENOSPHERE. ON EVALUATION OF THE UNCEMENTED STEM IN SITU, THE SURGEON DETECTED SLIGHT MOVEMENT OF THE IMPLANT AND WAS CONCERNED ABOUT STABILITY. THE UNCEMENTED STEM (SMR CEMENTLESS FINNED STEM Ø24, CODE 1304.15.240, LOT 1201838 STER. (B)(6) WAS THEN REMOVED AND A CEMENTED STEM WAS IMPLANTED. THE PREVIOUS SURGERY TOOK PLACE ON (B)(6)2021. THIS EVENT OCCURRED IN CANADA.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 23510710 ↗

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-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.
• 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