MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; SMR TT METAL BACK BASEPLATE (TI6AL4V) - SMALL R

Model Number	1375.15.605
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	06/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
Preliminary review of manufacturing records did not identify any pre-existing anomaly or non conformity on involved lot of baseplates that could have contributed to reported issue.The manufacturer will submit a final report as soon as the investigation is completed.

• Brand Name: SMR SHOULDER
• Common Device Name: SMR TT METAL BACK BASEPLATE (TI6AL4V) - SMALL R
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 25573951
• Report Number: 3008021110-2026-00260
• Device Sequence Number: 9083083
• Product Code: KWS
• UDI-Device Identifier: 08033390272797
• UDI-Public: 8033390272797
• Combination Product (Y/N): N
• PMA/510(K) Number: K133349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1375.15.605
• Device Lot Number: 2536262
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/22/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male