SMR System 1375.15.605Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033390272797), received between Feb 12, 2026 and Jun 22, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 reports).

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.

• InjuryJun 22, 2026Patient Device Interaction Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO GLENOID LOOSENING IN A STUDY PATIENT. ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2026 WHEN THE FOLLOWING ASSEMBLY HAS BEEN IMPLANTED: GLENOID BASEPLATE SMALL-R (PN 1375.15.605, LOT 2536262, STERILIZATION (B)(4)), GLENOID PEG SMALL-R #S (PN 1375.14.651, LOT 2515773, STERILIZATION (B)(4)), 2X BONE SCREW (PN 8420.15.010, LOTS 2530046 AND 2523197, STERILIZATION (B)(4) RESPECTIVELY), CONNECTOR SMALL +2MM (PN 1374.15.312, LOT 2513801, STERILIZATION (B)(4)), REVERSE HP GLENOSPHERE (PN 1374.50.440, LOT 2228852, STERILIZATION (B)(4)), SMR STEMLESS REVERSE CORE #L (PN 1355.14.238, LOT 2119985, STERILIZATION (B)(4)), SMR STEMLESS REVERSE LINER #S (PN 1365.09.445, LOT 2222639, STERILIZATION (B)(4)). NO ADVERSE EVENTS OCCURRED DURING SURGICAL PROCEDURE AND SURGEON USED A DELTO-PECTORAL APPROACH. MIGRATION OF THE BASEPLATE WAS NOTICED IN THE EARLY POST OPERATIVE PERIOD (AROUND 6 WEEKS POST OP). PATIENT WAS OPERATING TRACTORS AGAINST MEDICAL ADVICE. THE WHOLE ASSEMBLY HAS BEEN REMOVED DURING REVISION AND REPLACED WITH DJO ALTIVATE REVERSE. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Laxity

  MAUDE report 25573951 ↗
• InjuryFeb 12, 2026Patient Device Interaction Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO COMPONENT LOOSENING. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2025 TO IMPLANT FOLLOWING COMPONENTS: PRIMA STEM #2 (PN 1357.14.030, LOT 2224208, STERILIZATION (B)(4)), PRIMA REVERSE TRAY #MEDIUM (PN 1367.15.013, LOT 2419312, STERILIZATION (B)(4)), PRIMA REVERSE INSERT SHORT DIA36MM 0*CORR RETENTIVE (PN 1367.54.101, LOT 2124961, STERILIZATION (B)(4)), SMR TT BASEPLATE SMALL-R (PN 1375.15.605, LOT 2430324, STERILIZATION (B)(4)), SMR GLENOID PEG TT SMALL-R SHORT (PN 1375.14.651, LOT 2331269, STERILIZATION (B)(4)), SMR CONNECTOR SMALL-R (PN 1374.15.305, LOT 2430893, STERILIZATION (B)(4)), SMR GLENOSPHERE DIA36MM (PN 1374.09.111, LOT 2429216, STERILIZATION (B)(4)). DURING REVISION THE SURGEON REMOVED ALL ABOVE-MENTIONED GLENOID COMPONENTS, AS WELL AS THE REVERSE TRAY AND LINER TO IMPLANT A 6MM ECCENTRICAL ADAPTOR (PN 1367.15.706) AND A HUMERAL HEAD DIA46MM (PN 13.22.09.460) AND CONVERT THE PROSTHESIS FROM A REVERSE TO AN ANATOMIC CONFIGURATION. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1951. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Loose body in joint

  MAUDE report 24322375 ↗
• InjuryFeb 12, 2026Mechanical Problem; Detachment of Device or Device Component; Patient Device Interaction Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO GLENOID FAILURE. DURING REVISION, THE FOLLOWING PRE-EXISTING SHOULDER PROSTHESIS COMPONENTS WERE REMOVED: SMR GLENOID BASEPLATE SMALL-R (PN 1375.15.605, LOT 2511769, STERILIZATION (B)(4)), SMR GLENOID PEG TT SMALL-R #M (PN 1375.14.652, LOT 2514981, STERILIZATION (B)(4)), SMR CONNECTOR SMALL R (PN 1374.15.305, LOT 2509762, STERILIZATION (B)(4)), SMR GLENOSPHERE Ø 36MM (PN 1374.09.111, LOT 2512612, STERILIZATION (B)(4)), SMR REVERSE LINER + 6 MM (PN 1360.50.820, LOT 24AT5NV, STERILIZATION (B)(4)). SURGEON CONVERTED THE REMOVED REVERSE ASSEMBLY TO AN ANATOMIC CONFIGURATION IMPLANTING AN ADAPTOR 36MM FOR REVERSE BODY (PN 1352.15.200) AND A CTA HEAD DIA46MM (PN 1323.09.460). THE SURGERY WAS COMPLETED AS INTENDED. PREVIOUS SURGERY IS UNKNOWN. THE PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1943. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Laxity; Loose body in joint

  MAUDE report 24322374 ↗