SMR System 1377.50.010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033390272681), received between Nov 8, 2024 and Jan 30, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Degraded” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 30, 2026Degraded

  A SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 DUE TO WEAR OF THE LINER F.MET.BACK GLEN. STANDARD (PRODUCT CODE: 1377.50.010, LOT NUMBER: UNKNOWN). AS A RESULT, THE SURGEON CONVERTED THE IMPLANT TO A REVERSE CONFIGURATION AND EXPLANTED THE FOLLOWING COMPONENTS: - FINNED STEM DIA. 22 MM, L. 80 (PRODUCT CODE: 1304.15.220, LOT NUMBER: UNKNOWN). - HUMERAL HEAD DIA. 54 MM (PRODUCT CODE: 1322.09.540, LOT NUMBER: UNKNOWN). - ADAPTOR TAPER NEUTRAL (PRODUCT CODE: 1330.15.270, LOT NUMBER: 0804233, STERILIZATION NO.: 0800231) . - HUMERAL BODY FINNED (PRODUCT CODE: 1350.15.110, LOT NUMBER: UNKNOWN). - LINER F.MET.BACK GLEN. STANDARD (PRODUCT CODE: 1377.50.010, LOT NUMBER: UNKNOWN). - METAL-BACK GLENOID STANDARD (PRODUCT CODE: 1375.20.010, LOT NUMBER: UNKNOWN). THE INITIAL SHOULDER IMPLANTATION SURGERY WAS PERFORMED ON (B)(6) 2008. EVENT HAPPENED IN AUSTRALIA.

  Patient problems: Pain

  MAUDE report 24223083 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 FOR UNKNOWN REASON. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE PRODUCT INFORMATION FOR ORIGINAL IMPLANT. PRE-EXISTING ANATOMIC TOTAL SHOULDER ARTRHOPLASTY WITH STANDARD SIZE METAL-BACK AND POLY LINER GLENOID WAS CONVERTED TO A REVERSE TOTAL SHOULDER IMPLANTING A ECCENTRIC DIA36MM GLENOSPHERE (PN 1376.09.031) WITH A LATERALIZED +4MM CONNECTOR (PN 1374.15.324) ONTO THE ORIGINAL METAL BACK, AFTER REMOVING THE LINER (PN 1377.50.010). ON THE HUMERAL SIDE THE TORNIER PERFORM HUMERAL STEM WAS USED. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24210773 ↗
• InjuryNov 8, 2024Material Integrity Problem; Material Integrity Problem

  REVISION SHOULDER SURGERY ON (B)(6) 2024 DUE TO PAIN, LOSS OF RANGE OF MOTION OF SHOULDER AND LINER WEAR. PREVIOUS SURGERY PERFORMED ON (B)(6) 2023. THE PATIENT REPORTED SQUEAKING OF THE PROSTHESIS SINCE (B)(6) 2024 DURING CERTAIN MOVEMENTS, WHICH INTENSIFIED WITH INCREASED PAIN. THE FOLLOWING DEVICES WERE REPLACED DURING REVISION: · LINER F.MET.BACK GLEN.STANDARD (PRODUCT CODE: 1377.50.010, LOT. 22AT1YM - STER. (B)(4)) - SOLD IN US. · SMR HUMERAL HEAD Ø48 MM (PRODUCT CODE: 1322.09.480 , LOT. 2120289 - STER. (B)(4)) - SOLD IN US. · SMR UNCEMENT. GLENOID # STD (PRODUCT CODE: 1375.20.010, LOT. 2309307 - STER. (B)(4)) - NOT SOLD IN US. · BONE SCREW Ø6,5 H.35MM (PRODUCT CODE: 8420.15.040, LOT: 2322192 - STER. (B)(4)) - SOLD IN US. · BONE SCREW Ø6,5 H.35MM (PRODUCT CODE: 8420.15.040, LOT: 2322192 - STER. (B)(4)) - SOLD IN US. PATIENT: MALE, 66 YEARS OLD, APPROXIMATE HEIGHT (M): 1.86, APPROXIMATE WEIGHT (KG): 87. EVENT OCCURRED IN GERMANY.

  Patient problems: Implant Pain; Loss of Range of Motion

  MAUDE report 20639159 ↗