MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; GLENOPSHERE DIA. 36MM

Model Number	1374.09.111
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed on (b)(6) 2025 due to instability.Previous surgery was a reverse total shoulder arthroplasty for a fracture, at unknown date.No complete information regarding original implant has been provided either.Patient developed shoulder laxity after previous surgery and needed revision of the implant.Surgeon replaced pre-existing components with new lateralized +4mm connector (part number 1374.15.315), eccentrical glenosphere 36mm (part number 1376.09.031), reverse humeral body (part number 1351.15.010) and reverse liner +6mm (part number 1360.50.820).Surgery was completed as intended.Patient is female, date of birth (b)(6) 1952.The event occurred in the united states.
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.

• Brand Name: SMR SHOULDER
• Common Device Name: GLENOPSHERE DIA. 36MM
• 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: 24159385
• Report Number: 3008021110-2026-00020
• Device Sequence Number: 18392617
• Product Code: KWS
• UDI-Device Identifier: 08033390272230
• UDI-Public: 8033390272230
• Combination Product (Y/N): N
• PMA/510(K) Number: K163397
• 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): 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: 1374.09.111
• 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