TT MB Baseplate TT Glenoid (REF 1375.15.610)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033390089579), received between Nov 24, 2021 and Jul 9, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 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. How this data works · Data updated Oct 13, 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.

• InjuryJul 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO DISASSEMBLY OF COMPONENTS. BASEPLATE AND GLENOID PEG SEEMED TO HAVE DISASSOCIATED, 5 MONTHS AFTER SURGERY (EXACT DATE OF THE PREVIOUS SURGERY IS UNKNOWN). PATIENT WAS EXPERIENCING PAIN. THE FOLLOWING COMPONENT WAS REMOVED AND REPLACED WITH NEW ONE: SMR GLENOID BASEPLATE STANDARD (PART CODE 1375.15.610, LOT NUMBER 2218374, STERILIZATION (B)(6)). DURING REVISION SURGERY, THE FOLLOWING REVERSE COMPONENTS WERE IMPLANTED AS WELL: SMR CONNECTOR + SCREW SMALL/STD (PART CODE 1374.15.310, LOT NUMBER 2127512, STERILIZATION (B)(6). SMR GLENOSPHERE DIA. 40MM (PART CODE 1374.09.121, LOT NUMBER 2500906, STERILIZATION (B)(6)) SMR REVERSE LINER (PART CODE 1365.50.815, LOT NUMBER 23AT488, STERILIZATION (B)(6)). THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1957. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Implant Pain

  MAUDE report 22457622 ↗
• InjuryJan 7, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  REVISION SURGERY PERFORMED ON (B)(6)2024, DUE TO INFECTION. THIS WAS A PLANNED REVISION FOR A PATIENT WHO HAD AN INFECTION. THERE WAS NO IMPLANT FAILURE. THE FOLLOWING COMPONENTS WERE REMOVED: - SMR REVERSE LINER + 3 MM (PART CODE 1360.50.815, LOT NUMBER 23AT252, STERILIZATION NUMBER (B)(4)). - SMR GLENOSPHERE Ø 36MM (PART CODE 1374.09.111, LOT NUMBER 2400526, STERILIZATION NUMBER (B)(4)). - SMR SMALL/STD CONNECTOR +4 (PART CODE 1374.15.324, LOT NUMBER 2220794, STERILIZATION NUMBER (B)(4)). - SMR GLENOID PEG TT S/STD #M (PART CODE 1375.14.662, LOT NUMBER 2223558, STERILIZATION NUMBER (B)(4)). - SMR GLENOID BASEPLATE STANDARD (PART CODE 1375.15.610, LOT NUMBER 2309329, STERILIZATION NUMBER (B)(4)). THE COMPONENTS REMOVED WERE REPLACED WITH THE FOLLOWING NEW COMPONENTS: - SMR RETENTIVE LINER STD (PART CODE 1361.50.810, LOT 20AT149, STERILIZATION NUMBER (B)(4)). - SMR GLENOSPHERE Ø 36MM (PART CODE 1374.09.111, LOT NUMBER 2424117, STERILIZATION NUMBER (B)(4)). - SMR SMALL/STD CONNECTOR LAT +2 (PART CODE 1374.15.322, LOT NUMBER 2416523, STERILIZATION NUMBER (B)(4)). - SMR GLENOID PEG TT SMALL/STD #LONG (PART CODE 1375.14.663, LOT NUMBER 2104941, STERILIZATION (B)(4)). - SMR GLENOID BASE

  Patient problems: Medical device site infection

  MAUDE report 21090857 ↗
• InjuryNov 24, 2021Therapeutic or Diagnostic Output Failure; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Patient Device Interaction Problem

  SHOULDER REVISION SURGERY OF A SMR REVERSE IMPLANT PERFORMED ON (B)(6) 2021, DUE TO LOOSENING OF THE SMR GLENOID BASEPLATE STANDARD (PRODUCT CODE 1375.15.610, LOT #1908455 - STER. 1900325). ACCORDING TO THE COMPLAINT SOURCE, THE PATIENT WENT FOR A CHECK-UP VISIT ON (B)(6) 2020, REPORTING PAIN (ORIGIN OF PAIN WAS UNKNOWN). A BONE FRACTURE AND LOOSENING WERE DETECTED BETWEEN THE 2020 FOLLOW-UP AND 2021 REVISION. ON (B)(6) 2021, THE ENTIRE PROSTHESIS WAS REMOVED AND REPLACED WITH AN ANTIBIOTIC SPACER DUE TO GLENOID COMPONENT LOOSENING. INFECTION WAS SUSPECTED BUT THEN EXCLUDED BY CULTURES. DURING THE REVISION, THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR GLENOID BASEPLATE STANDARD (PRODUCT CODE 1375.15.610, LOT #1908455 - STER. 1900325). SMR GLENOSPHERE Ø 40MM (PRODUCT CODE 1374.09.121, LOT #1814499 - STER. 1800297). SMR GLENOID PEG TT S/STD/L #L (PRODUCT CODE 1375.14.663, LOT #1600895 - STER. 1600073). ACCORDING TO THE COMPLAINT SOURCE, THE PATIENT IS RECEIVING ANTIBIOTICS AND HIS POST-OPERATIVE CULTURE TESTS ARE STILL PENDING. THE SMR HYBRID ANATOMIC SHOULDER WAS ORIGINALLY IMPLANTED ON (B)(6) 2017. CONVERSION TO SMR REVERSE WAS PERFORMED ON (B)(6) 2019: THE EVENT WAS REGISTERED AS

  Patient problems: Bone Fracture(s); Failure of Implant; Joint Laxity; Pain

  MAUDE report 12868962 ↗