SMR System 1322.09.440Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08033390274074), received between Jan 26, 2026 and Feb 25, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Unstable” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2026Unstable; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED ON (B)(6) 2026. PATIENT PRESENTED WITH POSSIBLE INFECTION AND INSTABILITY. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2022, HOWEVER NO COMPLETE INFORMATION REGARDING ORIGINAL IMPLANT WAS PROVIDED. DURING REVISION THE SURGEON REMOVED THE PRE-EXISTING LINER FOR METAL BACK GLENOID STD (PART NUMBER: 1377.50.010), SMR FINNED HUMERAL BODY (PART NUMBER: 1350.15.110), SMR ECCENTRICAL ADAPTOR TAPER STD (PART NUMBER: 1330.15.274) AND SMR HUMERAL HEAD DIA44MM (PART NUMBER: 1322.09.440), AND CONVERTED THE PROSTHESIS TO A REVERSE CONFIGURATION USING A CONNECTOR (PN: 1375.15.310), GLENOSPHERE DIA 36MM (PN: 1374.09.111), HUMERAL REVERSE BODY 140° (PN: 1352.15.015) AND REVERSE LINER +3MM DIA36MM (PN: 1360.54.815). SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH ON (B)(6) 1962. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Medical device site infection

  MAUDE report 24442716 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS 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 PRE-EXISTING SMR TRAUMA HUM. BODY # MEDIUM (PART NUMBER: 1350.15.010), SMR HUMERAL HEAD Ø44 MM (PART NUMBER: 1322.09.440) AND SMR ECC. ADAPTOR TAPER STD +2MM (PART NUMBER: 1330.15.272) WERE REMOVED AND A REVERSE CONFIGURATION CONSISTING OF FOLLOWING COMPONENTS WAS IMPLANTED: GLENOSPHERE 36MM (PART NUMBER: 1374.09.111). LATERALIZED CONNECTOR +2MM (PART NUMBER: 1374.15.322). REVERSE 140° HUMERAL BODY (PART NUMBER: 1352.15.015). REVERSE LINER +6MM (PART NUMBER: 1360.50.820). SURGERY HAS BEEN COMPLETED AS INTENDED. PATIENT IS FEMALE. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 24197898 ↗
• InjuryJan 27, 2026Unstable

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO SHOULDER INSTABILITY. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS PRODUCT INFORMATION OF ORIGINAL PROSTHETIC ASSEMBLY. DURING REVISION THE SURGON REMOVED THE ANATOMIC COMPONENTS, INCLUDING THE HUMERAL HEAD DIA 44MM (PN 1322.09.440), IN ORDER TO CONVERT THE PROSTHESIS TO A REVERSE CONFIGURATION TO IMPROVE STABILITY. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1966. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Laxity

  MAUDE report 24187161 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO CUFF FAILURE. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS LOT NUMBERS OF ORIGINAL IMPLANT. PATIENT REQUIRED REVISION FROM TOTAL SHOULDER ARTHROPLASTY TO A REVERSE CONFIGURATION DUE TO THE ROTATOR CUFF TEAR. SURGEON REMOVED THE PRE-EXISTING SMR FINNED HUMERAL BODY (PART NUMBER 1350.15.110), NEUTRAL ADAPTOR TAPER STANDARD (PART NUMBER 1330.15.270), SMR HUMERAL HEAD Ø44 MM (PART NUMBER 1322.09.440) AND THE CEMENTED GLENOID SMALL-R (PART NUMBER 1378.50.005) AND IMPLANTED A COMBINATION OF REVERSE COMPONENTS SUCH AS GLENOSPHERE, REVERSE HUMERAL BODY AND REVERSE LINER. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1948. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 24178607 ↗

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.