MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SYSTEM; SMR SYSTEM - REVERSE HP GLENOSPHERE DIA. 40MM

Model Number	1374.50.400
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed on (b)(6) 2025 due to potential glenosphere loose from male connector in glenoid baseplate.Patient started to have more clicking and pain in shoulder 18 months prior.The symptoms were noticed over time and no specific event or injury.Patient otherwise fit and well.Two pieces of metal noted on recent x-rays from glenosphere wire.Glenosphere revised - most of metal wire removed but not all.A small fragment of wire could not be found.Previous surgery performed on (b)(6) 2020.The explanted devices: smr connector small std (product code: 1374.15.310, lot: 1810021 - ster: (b)(4) , smr reverse hp glenosph.40 mm (product code: 1374.50.400, lot: 2001378 - ster: (b)(4), smr reverse hp liner long (product code: 1365.09.020, lot: 1918642 - ster: (b)(4).Patient: male, 68 years old, height: 1.72m, weight: 82kg, occupation: diving, event occurred in united kingdom.
Additional Manufacturer Narrative
The device history records (dhrs) of involved lot numbers 2001378 and 1810021 were checked and no anomalies were detected on the pieces manufactured with these lot numbers.This is the first and only complaint received on lot numbers 2001378 and 1810021.A final report will be submitted once the investigation is completed.
Additional Manufacturer Narrative
The device history records (dhrs) for the involved lot numbers 2001378 and 1810021 were reviewed, and no anomalies were identified in the components manufactured under these lot numbers.This is the first and only complaint reported for lot numbers 2001378 and 1810021.The explant was lost during shipment from the hospital to our subsidiary in great britain.The complaint source provided several x rays (pre- and post - x-rays from previous an revision surgeries) and photos of the explant, which were forwarded to a medical expert for evaluation.Below is his comment on the case: "the case is a clear surgical problem.The radiographs show a malpositioned baseplate with superior angulation instead of downward angulation.Additionally, there is severe mechanical notching from the beginning.The long liner is another indicator of poor soft tissue balance.As a result, there is superior force to the glenosphere that have led to disconnection and apparently failure and destruction with metal debris as well.There is no sign for implant related failure, but the implant failed because of surgical mistakes." in conclusion, based on the fact that the dhrs review did not reveal any anomalies, this is the first and only complaint for the involved lot numbers, the explant was not returned for analysis (lost during transport), and the medical expert's evaluation indicates that the event is primarily due to surgical factors, we conclude that the event is not product related.Pms data according to pms the revision rate due to disassembly and/or breakage of reverse hp glenosphere (family code: 1374.50.Xxx) is nearly (b)(4).This is a final mdr report.
Event or Problem Description
Revision surgery performed on (b)(6) 2025 due to potential glenosphere loose from male connector in glenoid baseplate.Patient started to have more clicking and pain in shoulder 18 months prior.The symptoms were noticed over time and no specific event or injury.Patient otherwise fit and well.Two pieces of metal noted on recent x-rays from glenosphere wire.Glenosphere revised - most of metal wire removed but not all.A small fragment of wire could not be found.Previous surgery performed on (b)(6) 2020.The explanted devices: · smr connector small std (product code: 1374.15.310, lot: 1810021 - ster: 1800219) · smr reverse hp glenosph.40 mm (product code: 1374.50.400, lot: 2001378 - ster: 2000040) · smr reverse hp liner long (product code: 1365.09.020, lot: 1918642 - ster: 1900463) patient: male, 68 years old, height: 1.72m, weight: 82kg, occupation: diving, event occurred in united kingdom.

• Brand Name: SMR SYSTEM
• Common Device Name: SMR SYSTEM - REVERSE HP GLENOSPHERE DIA. 40MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: villanova di san daniele
• MDR Report Key: 24108817
• Report Number: 3008021110-2026-00031
• Device Sequence Number: 5816081
• Product Code: PHX
• UDI-Device Identifier: 08033390061230
• UDI-Public: 08033390061230
• Combination Product (Y/N): N
• PMA/510(K) Number: K243826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 04/02/2026

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: 1374.50.400
• Device Catalogue Number: 1374.50.400
• Device Lot Number: 2001378
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 01/19/2026
• Supplement Report FDA Received Date: 04/03/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown