TT MB Baseplate TT Glenoid (REF 1375.15.605)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08033390089562), received between May 6, 2025 and Jul 29, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2026Patient Device Interaction Problem

  SMR Reverse implant revision was performed on (b)(6) 2026 due to aseptic loosening of the glenoid baseplate. During the procedure, the surgical site was prepared and soft tissues were exposed to allow access to the implants. Multiple specimens were collected from both humeral and glenoid soft tissues prior to implant removal.The surgeon first removed the humeral components, followed by the glenoid and baseplate components. The site was subsequently prepared for reimplantation using Stryker components.The previous surgery had been performed on (b)(6) 2022.The surgeon confirmed that the standard surgical workflow for shoulder revision was followed. The following components were explanted: SMR GLENOID BASEPLATE SMALL-R (Product code 1375.15.605, Lot 2015597, Ster. No. (b)(4), SMR CEMENTLESS FINNED STEM (Product code 1304.15.150, Lot 2119508, Ster. No. (b)(4), SMR REVERSE HUMERAL BODY (Product code 1352.20.010, Lot 2119837, Ster. No. (b)(4), SMR REVERSE HP LINER SHORT (Product code 1365.09.010, Lot 2116005, Ster. No. (b)(4), SMR REVERSE HP GLENOSPH. 40 MM (Product code 1374.50.400, Lot 2121399, Ster. No.(b)(4), SMR GLENOID PEG TT SMALL-R #L (Product code 1375.14.653, Lot 2108651, Ster.

  Patient problems: Aseptic loosening

  MAUDE report 50066815 ↗
• InjuryJan 26, 2026Patient Device Interaction Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO LOOSENING. PATIENT RECEIVED A REVERSE TOTAL SHOULD ARTHROPLASTY WITH SMR STEM, REVERSE HUMERAL BODY (PN 1352.15.010), REVERSE LINER STD (PN 1360.50.810), 36MM GLENOSPHERE WITH CONNECTOR (1374.09.105) AND SMR METAL BACK BASEPLATE (PN 1375.15.605) AT AN UNKNOWN DATE PRIOR TO 2020. RECORDS COULD NOT BE FOUND OF ORIGINAL IMPLANTS. DUE TO OSTEOLYSIS AROUND THE BASEPLATE, POSSIBLY DUE TO MAL-POSITIONED BASEPLATE OR NOTCHING, THE GLENOID CONSTRUCT WAS DEEMED UNSTABLE AND LOOSE. UPON REVISION, ABOVE MENTIONED COMPONENTS, WITH EXCEPTION OF THE HUMERAL STEM, WERE EASILY REMOVED. AN ANATOMIC HUMERAL BODY TRAUMA MEDIUM (PN 1350.15.010) AND HUMERAL HEAD DIA42MM (PN 1322.09.420) WERE IMPLANTED WITH ECCENTRICAL ADAPTOR TAPER 2MM LONG (PN 1331.15.272), AND THE BONE LOSS ON GLENOID WAS FILLED WITH BONE GRAFT FOR A POTENTIAL SECOND STAGE REVISION SURGERY TO IMPLANT A REVERSE BASEPLATE. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF (B)(6) 1944. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Loose body in joint

  MAUDE report 24178569 ↗
• InjuryJan 26, 2026Patient Device Interaction Problem

  TOTAL SHOULDER REVISION SURGERY OF AN SMR REVERSE IMPLANT WAS PERFORMED ON (b)(6)H, 2026, DUE TO ASEPTIC LOOSENING OF THE SMR GLENOID BASEPLATE SMALL-R (PRODUCT CODE 1375.15.605, LOT #2011657 - STER. 2000258). THE SURGEON EXPOSED THE SURGICAL SITE AND EXPLANTED THE LINER, HUMERAL BODY, STEM, GLENOSPHERE, AND BASEPLATE. THE BASEPLATE WAS THEN PREPARED FOR IMPLANTATION OF A NEW GLENOID COMPONENT USING A COMPETITOR IMPLANT SYSTEM.THE FOLLOWING DEVICES WERE EXPLANTED DURING THE REVISION PROCEDURE:· SMR REVERSE HP LINER MEDIUM (PRODUCT CODE 1365.09.015, LOT #2005901 - STER. 2000208)· SMR REVERSE HUMERAL BODY (PRODUCT CODE 1352.20.010, LOT #2006792 - STER. 2000210)· SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.190, LOT #2009886 - STER. 2000210)· SMR CONNECTOR SMALL-R (PRODUCT CODE 1374.15.305, LOT #2011115 - STER. 2000230)· SMR GLENOID PEG TT SMALL-R #L (PRODUCT CODE 1375.14.653, LOT #2007768 - STER. 2000172)· SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE 1374.50.400, LOT #2013168 - STER. 2000245)· SMR GLENOID BASEPLATE SMALL-R (PRODUCT CODE 1375.15.605, LOT #2011657 - STER. 2000258)· BONE SCREW Ø6.5 H.25MM (PRODUCT CODE 8420.15.020, LOT #2002713 - STER. 2000126)· BONE SCREW Ø6.5 H.

  Patient problems: Joint Laxity

  MAUDE report 24176099 ↗
• InjuryJul 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  REVISION SURGERY WAS PERFORMED ON JUNE 3RD, 2025, DUE TO PATIENT'S POOR BONE QUALITY AND THE IMPLANT LOOSENED. THE FOLLOWING COMPONENTS WERE REMOVED: SMR GLENOID PEG TT SMALL-R #S (PART CODE 1375.14.651, LOT NUMBER 1600393, STERILIZATION (B)(4). SMR GLENOID BASEPLATE SMALL-R (PART CODE 1375.15.605, LOT NUMBER 1608246, STERILIZATION (B)(4). SMR GLENOSPHERE Ø36MM SMALL-R (PART CODE 1376.09.025, LOT NUMBER 1618000, STERILIZATION (B)(4). THE DATE OF THE PREVIOUS SURGERY IS UNKNOWN. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Joint Laxity

  MAUDE report 22518008 ↗
• InjuryMay 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2025, FOLLOWING THE INITIAL SURGERY PERFORMED ON (B)(6) 2024. OVER THE PAST SIX MONTHS, THE PATIENT BEGAN EXPERIENCING PAIN, WHICH LED TO A CLINIC VISIT WHERE IMAGING REVEALED DISENGAGEMENT OF THE GLENOID COMPONENTS FROM HER GLENOID. DURING THE REVISION SURGERY THE FOLLOWING COMPONENTS WERE REMOVED: SMR SMALL-R CONNECTOR +2 (PART CODE: 1374.15.312, LOT NUMBER: 2409580, STERILIZATION: 2400084). SMR ECCENT. GLENOSPHERE DIA. 36MM (PART CODE: 1376.09.031, LOT NUMBER 2414117, STERILIZATION 2400119) SMR REVERSE LINER + 6 MM (PART CODE 1360.50.820, LOT NUMBER: 23AT40J, STERILIZATION: 2400057). SMR GLENOID BASEPLATE SMALL-R (PART CODE: 1375.15.605, LOT NUMBER: 2409099, STERILIZATION: 2400098). THE ABOVE-MENTIONED CONNECTOR, LINER AND GLENOSPHERE WERE REPLACED BY THE FOLLOWING NEW ONES: SMR SMALL-R CONNECTOR (PART CODE: 1374.15.305, LOT NUMBER: 2407409, STERILIZATION: 2400067). SMR ECCENT. GLENOSPHERE DIA. 36MM (PART CODE: 1376.09.031, LOT NUMBER: 2434937, STERILIZATION: 2500010). SMR REVERSE LINER +6 MM (PART CODE: 1360.50.820, LOT NUMBER: 24AT3VD, LOT NUMBER: 2400253). THE PATIENT IS A FEMALE, DATE OF BIRTH ON (B)(6) 1962. THE EVENT HAPPENE

  Patient problems: Implant Pain

  MAUDE report 21968718 ↗