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

Model Number	1374.09.121
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	04/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: checking the manufacturing charts, no pre-existing anomaly has been discovered on the (b)(4) items manufactured with the same product code and lot number as the device removed in this event.According to the records available, all the items belonging to the part code 1374.09.121, lot number 2201768 and sterilization (b)(4) have been implanted and this is the first and only complaint received on this lot.We have received no additional information on this event; therefore, we cannot carry out further investigation.However, considering that: - no pre-existing anomaly was discovered by checking the manufacturing charts of the lot number of the component involved in the event.- this is the only complaint received on this lot.We have no evidence to consider the event as product related.Pms data: based on the relevant pms data, the revision rate of the glenospheres belonging to the family codes (b)(4) due to loosening 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 loosening.Patient presented with a loose humeral component.The following glenosphere was removed and replaced by a new glenosphere (diameter 42 mm): - smr glenosphere dia.40mm (part code 1374.09.121, lot number 2201768, sterilization (b)(4)).The date of previous surgery is unknown.The patient is a male, date of birth (b)(6) 1953.The event happened 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: 22159543
• Report Number: 3008021110-2025-00071
• Device Sequence Number: 7484708
• Product Code: MBF
• UDI-Device Identifier: 08033390123129
• UDI-Public: 08033390123129
• 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): 06/06/2025

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: 1374.09.121
• Device Lot Number: 2201768
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2025
• 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