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

Model Number	1376.09.041
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Checking the manufacturing charts of the components involved in this event, no pre-existing anomaly was found in the 60 items belonging to the lot number 2405201, nor in the (b)(4) items belonging to the lot number 2408266.This is the first and only complaint received about these lot numbers.We did not receive any additional information on this event, so we are not able to perform further investigation.However, taking into account that: - no pre-existing anomalies were found by checking the manufacturing charts of the lot number 2405201 and lot number 2408266.- this is the first complaint received about these lots.We have no evidence to consider the event as product related.Pms data based on the available pms data, the revision rate of the smr glenosfere belonging to the family product codes 1374/1376.09.Xxx - 1374/1376.15.Xxx due to dislocation is around (b)(4).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 implant dislocation.Patient was in a skilled nursing facility and a provider pulled on his arm and ripped out the baseplate.When the surgeon revised him, the entire baseplate, screws and glenosphere all came out easily, so the surgeon went with a larger baseplate and longer screws and replaced the poly in the revision.The following components were removed and replaced by new ones: - smr metal-back glenoid std (part code 1375.21.010, lot number 2408266, sterilization (b)(4)).- smr eccent.Glenosphere ø 40mm (part code 1376.09.041, lot number 2405201, sterilization (b)(4)).- smr connector small std (part code 1374.15.310, lot number 2426988, sterilization (b)(4)).- smr reverse liner retentive (part code 1365.50.821, lot number 24at0y0, sterilization (b)(4)).Previous surgery performed on (b)(6) 2025.The subsequent revision surgery (performed on (b)(6) 2025) was registered as complaint (b)(4) (reported with mfr.3008021110-2025-00098).The patient is a male, date of birth (b)(6).The event happened in the united states.

• 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: 22872907
• Report Number: 3008021110-2025-00107
• Device Sequence Number: 18738515
• 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): 08/22/2025

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: 2405201
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2025
• 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