SMR System 1374.09.105Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033390272216), received between May 17, 2023 and Nov 11, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 other recall cover devices cleared under the same FDA submission (K110598); 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.

• MalfunctionNov 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A SURGERY ON (B)(6) 2025, THE SURGEON IMPLANTED THE METAL-BACK GLENOID SMALL-R (PRODUCT CODE: 1375.20.005 - LOT: 2513700 - STER: (B)(4) AND FIXED IT WITH TWO SCREWS, AS PLANNED. AFTER THAT, THE 36 GLENOSPHERE (PRODUCT CODE: 1374.09.105 - LOT: 2514000 - STER: (B)(4) WAS CONNECTED TO THE CONNECTOR FROM THE SAME PACKAGE AND ATTACHED TO THE IMPACTOR, WHICH WAS FULLY SECURED. THE ASSEMBLY WAS PLACED IN SITU USING A MALLET. HOWEVER, THE GLENOSPHERE COULD NOT BE FIXED. CONSEQUENTLY, THE SURGEON REMOVED IT, DISCONNECTED THE CONNECTOR FROM THE GLENOSPHERE, AND FIXED IT TO THE METAL-BACK. A FURTHER ATTEMPT TO PLACE THE GLENOSPHERE WAS MADE, BUT AGAIN IT WAS NOT POSSIBLE. THE SCREWS, THE METAL-BACK, AND THE CONNECTOR WERE REMOVED TOGETHER. THE CONNECTOR WAS THEN DETACHED FROM THE METAL-BACK, AND THE IMPLANTATION PROCESS WAS RESTARTED, YET THE SAME ISSUE OCCURRED. AS A RESULT, THE SURGEON REMOVED THE COMPONENTS AND CHANGED TO A METAL-BACK SMALL AND THE SUITABLE GLENOSPHERE 36 AND CONNECTOR. THERE WAS SUFFICIENT BONE STOCK AT THE GLENOID, ALLOWING THE IMPLANTS TO BE PLACED IN SITU WITHOUT ANY FURTHER ISSUES. THE PHYSICIAN WHO PERFORMED THE SURGERY IS AN SMR-EXPERIENCED SURGEON. THERE WAS

  Patient problems: Insufficient Information

  MAUDE report 23523309 ↗
• InjuryMay 17, 2023Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2018: ROUTINE POST OP X-RAYS REVEALED A SUBLUXED HUMERAL PROSTHESIS. THE GLENOSPHERE WAS UPSIZED TO A 40 MM GLENOSPHERE. DURING THIS REVISION SURGERY, THE FOLLOWING DEVICES WERE EXPLANTED: - SMR REV. LINER RETENTIVE +6 MM CODE 136150020, LOT 15AT1H5. - SMR GLENOSPHERE Ø36MM SMALL-R CODE 137409105, LOT 1713817. THE PREVIOUS SURGERY WAS CARRIED OUT ON (B)(6) 2018 AND IT WAS A REVISION SURGERY. (REGISTERED AS COMPLAINT 153/23, NOT REPORTED TO FDA AS THE INVOLVED PRODUCT IS NOT MARKETED IN THE US). THE COMPLAINT SOURCE REPORTED POOR MUSCLE CONTROL AFTER CEMENT SPACER FOR SEVERAL MONTHS AND INSTABILITY WITH THE 36 MM LONG RETENTIVE LINER. THIS EVENT OCCURRED IN THE UNITED KINGDOM. NOTE: THE PRODUCT CODE 136150020 IS NOT MARKETED IN THE US.

  Patient problems: Joint Dislocation

  MAUDE report 16945189 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110598. One submission often covers many models, so check the product and lot details in each record.

• Z-1711-2016 · Apr 8, 2016 · Terminated
  SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.