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	Joint Laxity (4526)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
Investigation: checking the manufacturing charts of the removed components, no pre-existing anomaly was discovered by checking the manufacturing charts of the items belonging to the same product codes and lot numbers as the devices involved in this event.This is the first and only complaint received about these lot numbers.Neither x-rays nor clinical data were available, therefore no further investigation can be carried out on this event.However, according to the information received from the complaint source, the patient had poor bone quality, and this circumstance is suspected to be the main reason for the revision surgery.Hence, taking into account that: no pre-existing anomaly has been discovered by checking the manufacturing charts of the involved lot numbers the patient had poor bone quality.We can conclude that the event is not product related.Pms data according to pms data, revision rate of smr glenoid baseplate, belonging to the family codes 1375.15.605/610/620, due to aseptic loosening is around 0.33%.Based on the root cause analysis performed and according to the relevant pms data, no corrective action is required for this specific case.The manufacturer will continue monitoring the market to promptly detect any further similar issue.Note: this is a combined initial-final mdr.

• 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: 22518008
• Report Number: 3008021110-2025-00093
• Device Sequence Number: 9231384
• 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 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): 07/16/2025

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: 1608246
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2025
• 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