SMR Shoulder Eccentrical GlenosphereRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033390002554), received between May 21, 2019 and May 21, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 16, 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 21, 2019Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  PRIMARY SHOULDER REVERSE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2018. SINCE THE PRIMARY SURGERY TOOK PLACE, THE PATIENT HAS BEEN SUFFERING OF SWELLING AND PUS OF UNKNOWN CAUSE. TEST RESULTED TO BE NEGATIVE FOR EXPOSURE TO BACTERIA AND INFECTION SOURCE HAS NOT BEEN IDENTIFIED YET. IT HAS BEEN REPORTED THAT PROBABLY THE PATIENT IS ALLERGIC TO METAL. REVISION SURGERY WILL BE PERFORMED AS SOON A SOLUTION FOR THE PATIENT WILL BE DEFINE. THE COMPONENT IMPLANTED DURING THE PRIMARY SURGERY ARE THE FOLLOWING: SMR CEMENTLESS FINNED STEM, CODE 1304.15.160, LOT #1800893, STER. 1800107. SMR REVERSE HUMERAL BODY, CODE 1352.15.010, LOT #1802167, STER. 1800073. SMR REVERSE LINER + 3 MM, CODE 1360.50.015, LOT #17AT25U, STER. 1800011. SMR METAL-BACK GLENOID SMALL R, CODE 1375.21.005, LOT #1801431, STER. 1800073. SMR GLENOSPHERE Ø36MM SMALL-R, CODE 1376.09.025, LOT #1704993, STER. 1700150. BONE SCREW Ø6,5 H.25MM, CODE 8420.15.020, LOT #1714960, STER. 1800028. BONE SCREW Ø6,5 H.40MM, CODE 8420.15.050, LOT #1518227, STER. 1500396. EVENT OCCURRED IN (B)(6).

  Patient problems: Hypersensitivity/Allergic reaction; Medical device site infection; Purulent Discharge; Swelling

  MAUDE report 8627569 ↗

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.