MAUDE Adverse Event Report: LIMACORPORATE S.P.A. TT MB BASEPLATE; 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	Implant Pain (4561)
Date of Event	03/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
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 happened in the united states.
Additional Manufacturer Narrative
Checking the manufacturing charts of the lot number: 2409099, no pre-existing anomaly was found in the (b)(4) items belonging to this lot.The manufacturer will submit a final mdr as soon as the investigation is complete.

• Brand Name: TT MB BASEPLATE
• 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: 21968718
• Report Number: 3008021110-2025-00043
• Device Sequence Number: 12887525
• Product Code: KWS
• UDI-Device Identifier: 08033390089562
• UDI-Public: 08033390089562
• Combination Product (Y/N): N
• PMA/510(K) Number: K133349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/06/2025

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: 2409099
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2025
• 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