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

Model Number	1376.09.041
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	08/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed on (b)(6) 2025, due to instability.Patient underwent a reverse total shoulder 2 months ago with lima smr.Patient began experiencing instability and returned to or for increased glenosphere lateralization and poly swap.The following components were removed and replaced by new ones: reverse liner +3 mm d.40 mm (part code: 1365.54.815, lot number: 23at3z2, sterilization: 2400028).Smr eccent.Glenosphere ø 40mm (part code: 1376.09.041, lot number: 2501637, sterilization: 2500038).Smr small/std connector +2 (part code: 1374.15.322, lot number: 2506233, sterilization: 2500072).Previous surgery took place on (b)(6) 2025.The patient is a male, date of birth on (b)(6) 1961.The event happened in the united states.
Additional Manufacturer Narrative
Investigation: checking the manufacturing charts of the reverse liner and the glenosphere involved in this event, no pre-existing anomaly was discovered in the 19 items belonging to the lot number: 23at3z2 and sterilization: 2400028, nor in the (b)(4) items belonging to the lot number: 2501637 and sterilization: 2500038.This is the first and only complaint registered on these lot numbers.We did not receive any additional information on this event (i.E., x-rays); therefore, we are not able to carry out any further investigation about the cause of the osteolysis reported.However, taking into account that: no pre-existing anomalies were found by checking the manufacturing charts of the reverse liner and the glenosphere removed in the revision surgery hereby reported we have no evidence to consider the event as product related.Pms data: according to the available pms data, the revision rate of the glenospheres belonging to the family product codes: 1374/1376.09.Xxx and 1374/1376.15.Xxx due to instability is around (b)(4).Based on the root cause analysis performed and according to the relevant pms data, no corrective actions are required for this specific case.The manufacturer will continue monitoring the market to promptly detect any further similar issues.Note: this is a combined initial-final mdr.

• Brand Name: SMR SHOULDER
• Common Device Name: ECCENTRICAL 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: 23084383
• Report Number: 3008021110-2025-00119
• Device Sequence Number: 21262428
• Product Code: MBF
• UDI-Device Identifier: 08033390123112
• UDI-Public: 08033390123112
• Combination Product (Y/N): N
• PMA/510(K) Number: K163397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 09/18/2025

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: 1376.09.041
• Device Lot Number: 2501637
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2025
• 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