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

Model Number	1376.09.031
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation checking the manufacturing charts of the components involved in this event, no pre-existing anomalies were found in the items belonging to the same product code and lot number as the devices removed in the revision surgery hereby reported.No additional information is available about this event, therefore we are not able to carry out further investigation.However, taking into account that: no pre-existing anomalies were discovered by checking the manufacturing charts of the components involved in this event.This is the only complaint registered on these lot numbers.We have no evidence to consider the event as product related.Pms data according to the available pms data, the occurrence rate of revision surgeries that involve the smr glenospheres belonging to the family product codes 1374.09.Xxx - 1376.09.Xxx - 1374.15.Xxx - 1376.15.Xxx due to loosening is around 0.05%.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 combined initial-final mdr.
Event or Problem Description
Revision surgery performed on (b)(6) 2025, due to component loosening.The date of the previous surgery is unknown.The following components were removed: smr reverse humeral body (part code 1352.15.010, lot number 2315575, sterilization (b)(4).Smr reverse liner standard (part code 1360.50.810, lot number 23at1tb, sterilization (b)(4).Smr eccent.Glenosphere ø 36mm (part code 1376.09.031, lot number 2317656, sterilization (b)(4).The reverse humeral body and the reverse liner were replaced by new components, while the glenosphere was replaced by a component from a different manufacturer.During this revision, the whole system implanted on the glenoid side belongs to a different manufacturer.The next surgery was performed on (b)(6) 2025.This next revision was reported as internal complaint (b)(4) and reported to the fda with mfr.3008021110-2025-00022.The patient is a female, date of birth (b)(6) 1965.The event happened in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: ECCENTRICAL GLENOSPHERE DIA. 36 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: 23298436
• Report Number: 3008021110-2025-00130
• Device Sequence Number: 17340145
• Product Code: MBF
• UDI-Device Identifier: 08033390087834
• UDI-Public: 08033390087834
• 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): 10/15/2025

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: 1376.09.031
• Device Lot Number: 2317656
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• 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