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	Loose body in joint (4926)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
Review of manufacturing records of explanted components did not highlight any pre-existing anomaly that could have contributed to reported issue.The manufacturer will provide 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: 24322375
• Report Number: 3008021110-2026-00062
• Device Sequence Number: 9912320
• 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: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/12/2026

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: 2430324
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2026
• 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: Unknown