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

Model Number	1375.15.610
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	04/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed on (b)(6) 2025, due to disassembly of components.Baseplate and glenoid peg seemed to have disassociated, 5 months after surgery (exact date of the previous surgery is unknown).Patient was experiencing pain.The following component was removed and replaced with new one: smr glenoid baseplate standard (part code 1375.15.610, lot number 2218374, sterilization (b)(4).During revision surgery, the following reverse components were implanted as well: smr connector + screw small/std (part code 1374.15.310, lot number 2127512, sterilization (b)(4), smr glenosphere dia.40mm (part code 1374.09.121, lot number 2500906, sterilization (b)(4).Smr reverse liner (part code 1365.50.815, lot number 23at488, sterilization (b)(4).The patient is a male, date of birth (b)(6)1957.The event happened in the united states.
Additional Manufacturer Narrative
Checking the manufacturing charts of the component involved in this event, no pre-existing anomaly was found out in the (b)(4) items belonging to the lot number 2218374.The manufacturer will submit a final mdr as soon as the investigation is complete.
Event or Problem Description
Revision surgery performed on (b)(6) 2025, due to disassembly of components.Baseplate and glenoid peg seemed to have disassociated, 5 months after surgery (exact date of the previous surgery is unknown).Patient was experiencing pain.The following component was removed and replaced with new one: smr glenoid baseplate standard (part code 1375.15.610, lot number 2218374, sterilization (b)(6)).During revision surgery, the following reverse components were implanted as well: smr connector + screw small/std (part code 1374.15.310, lot number 2127512, sterilization (b)(6).Smr glenosphere dia.40mm (part code 1374.09.121, lot number 2500906, sterilization (b)(6)) smr reverse liner (part code 1365.50.815, lot number 23at488, sterilization (b)(6)).The patient is a male, date of birth (b)(6) 1957.The event happened in the united states.
Additional Manufacturer Narrative
Investigation: checking the manufacturing charts of the component involved in this event, no pre-existing anomaly was found out in the (b)(4) items belonging to the lot number 2218374.This is the first and only complaint received on this lot number.The manufacturer tried to ask for additional information about the part code and lot number of the peg disassociated, but without success.Therefore we cannot further investigate the event, in particular with the aim of excluding any off-label use; according to the labelling of the smr glenoid baseplate standard with part code 1375.15.610, this component is allowed to be coupled only with pegs with specific part codes, but we do not know if the part code of the peg disassociated is included in the allowed combination or not.Thus, based on the available information: no pre-existing anomaly was found by checking the manufacturing charts of the baseplate involved in this adverse event.We did not receive any further information on the peg.We have no evidence to consider the event as 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 loosening/disassembly with the peg is around (b)(4).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 final mdr.

• Brand Name: TT MB BASEPLATE
• Common Device Name: SMR TT METAL BACK BASEPLATE (TI6AL4V) - STANDARD
• 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: 22457622
• Report Number: 3008021110-2025-00086
• Device Sequence Number: 8443423
• Product Code: KWS
• UDI-Device Identifier: 08033390089579
• UDI-Public: 08033390089579
• 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,Followup
• Report Date (Section B): 09/01/2025

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: 1375.15.610
• Device Lot Number: 2218374
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 09/02/2025
• 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