MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; GLENOSPHERE DIA. 40 MM

Model Number	1374.09.121
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Laxity (4526); Medical device site infection (4845)
Date of Event	02/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explanted components have been discarded therefore cannot be returned to manufacturer for identification and analysis.No review of manufacturing records for complained parts can be performed either since lot number is unknown.No x-rays nor pictures of explanted components were provided either.From follow-up communication with complaint source it was confirmed that no further information regarding the case can be retrieved, therefore no further root cause investigation is possible.Taking into account the involved product family smr shoulder, no adverse trend has been identified for reported issue in the last year.According to investigation carried out, no corrective action is needed for this event.The manufacturer will continue monitoring the market in order to detect any similar event.
Event or Problem Description
Revision surgery was performed on (b)(6) 2025 due to infection and instability of glenosphere connector, glenosphere and humeral stem.Previous surgery is unknown, as well as complete product information of original implant.During revision the surgeon explanted the involved components on the glenoid side and replaced them with new lateralized connector +2mm small (part number 1374.15.312), glenosphere 40mm (part number 1374.09.121) and a new reverse liner retentive std dia40mm (part number 1365.50.811) on humeral side for renewal reasons.Surgery was completed as intended.Patient is male, date of birth (b)(6)1960.The event occurred in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: GLENOSPHERE DIA. 40 MM
• 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: 24159384
• Report Number: 3008021110-2026-00018
• Device Sequence Number: 21082900
• Product Code: KWS
• UDI-Device Identifier: 08033390123129
• UDI-Public: 8033390123129
• Combination Product (Y/N): N
• PMA/510(K) Number: K163397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 01/23/2026

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: 1374.09.121
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2026
• 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