SMR Shoulder 1352.15.015Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033390268240), received between May 26, 2026 and Jul 29, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 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.

• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  A shoulder reverse implant revision was performed on (b)(6) 2026 due to infection. A deltoid split approach was used; the liner, humeral body were removed and all signs of infection around the top of the stem were addressed. The glenoid was exposed and the glenosphere was removed. The joint was thoroughly washed out using 4 to 5 bags of 2L saline solution. New implants were then inserted "[?]" glenosphere, liner and humeral body "[?]" followed by a final washout with additional saline prior to closure of the shoulder joint. Previous surgery was performed on (b)(6) 2026.The surgeon followed the standard surgical workflow for shoulder revision. The explanted components included:· REVERSE #SHORT HUM. BODY 140° (Product code 1352.15.015, lot 2601033, ster. n. 2600034).· SMR REV. HP LAT. LINER MEDIUM (Product code 1365.09.115, lot 2530328, ster. n. 2500239).· SMR SMALL/STD CONNECTOR +2 (Product code 1374.15.322, lot 2541225, ster. n. 2600017).· SMR REVERSE HP GLENOSPH. 40 MM (Product code 1374.50.400, lot 2616231, ster. n. 2600105).Patient is Male, 74 years old.Event happened in Australia.

  Patient problems: Medical device site infection

  MAUDE report 50066787 ↗
• InjuryMay 26, 2026Unstable; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY HEREBY REPORTED HAS BEEN PERFORMED ON (B)(6) 2026, DUE TO UNDERLYING INFECTION, CHRONIC INSTABILITY AND CONSEQUENT DISLOCATION. PATIENT WAS ORIGINALLY IMPLANTED WITH SMR REVERSE PROSTHESIS. ORIGINAL PROSTHETIC ASSEMBLY CONSISTED OF BASEPLATE, LATERALIZED CONNECTOR +4MM, GLENOSPHERE ECCENTRIC DIA 40MM AND SMR HUMERAL BODY REVERSE (PART NUMBER 1352.15.010, LOT UNKNOWN). 9/10 YEARS LATER, FIRST REVISION SURGERY OCCURRED (B)(6) 2025) DUE TO INFECTION: HUMERAL BODY HAS BEEN EXPLANTED AND REPLACED WITH A NEW ONE (COMPLAINT ASSOCIATED TO MFR # 3008021110-2026-00010). ON (B)(6) 2026, SECOND REVISION SURGERY HAS BEEN PERFORMED DUE TO UNKNOWN REASONS (MFR # 3008021110-2026-00241) AND PRE-EXISTING HUMERAL BODY AND GLENOID COMPONENTS HAS BEEN EXPLANTED AND REPLACED WITH NEW ONES. A THIRD REVISION SURGERY OCCURRED ON (B)(6) 2026, DUE TO UNKNOWN REASONS, AND HUMERAL BODY AND GLENOID COMPONENTS, EXCEPT FOR THE BASEPLATE, HAS BEEN EXPLANTED (MFR # 3008021110-2026-00242) AND REPLACED. THEREFORE, AT THE TIME OF THE FOURTH REVISION SURGERY, HEREBY REPORTED, THE IMPLANT WAS CONSISTING OF: STEM ORIGINALLY IMPLANTED 140° HUMERAL BODY REVERSE (PN 1352.15.015, LOT. 2430583, STER. (B)(4);

  Patient problems: Joint Dislocation; Medical device site infection

  MAUDE report 25280182 ↗