MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER; TRAUMA HUMERAL BODIES WITH LOCKING SCREW MEDIUM

Model Number	1350.15.010
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Checking the manufacturing charts of the removed components, no pre-existing anomaly was discovered in the items belonging to the same product codes and lot numbers as the devices involved in this event.The manufacturer will submit a final mdr as soon as the investigation is complete.
Event or Problem Description
Revision surgery performed on (b)(6) 2025, due to loosening.Patient had a lima anatomic replacement at unknown prior date.Due to loosening of cemented 3-pegged glenoid component, significant osteolysis occurred.After removing the glenoid component, a mixture of bone graft and demineralized bone matrix was used to pack the defect.This was the second stage in the two-stage revision process.The following anatomic body, head and adaptor were removed: - smr humeral head ø44 mm (part code 1322.09.440, lot number 1919684, sterilization (b)(4)) - smr ecc.Adaptor taper standard (part code 1330.15.272, lot umber 2023555, sterilization (b)(4)).- smr trauma hum.Body # medium (part code 1350.15.010, lot number 2023593, sterilization (b)(4)).A reverse body and prima tt baseplate were implanted into the previously grafter glenoid.The patient is a male, date of birth (b)(6)1953.The event happened in the united states.
Event or Problem Description
Revision surgery performed on (b)(6) 2025, due to loosening.Patient had a lima anatomic replacement at unknown prior date.Due to loosening of cemented 3-pegged glenoid component, significant osteolysis occurred.After removing the glenoid component, a mixture of bone graft and demineralized bone matrix was used to pack the defect.This was the second stage in the two-stage revision process.The following anatomic body, head and adaptor were removed: smr humeral head ø44 mm (part code 1322.09.440, lot number 1919684, sterilization 2000024).Smr ecc.Adaptor taper standard (part code 1330.15.272, lot number 2023555, sterilization 2100038).Smr trauma hum.Body # medium (part code 1350.15.010, lot number 2023593, sterilization 2100038).A reverse body and prima tt baseplate were implanted into the previous grafter glenoid.The patient is a male, date of birth (b)(6) 1953.The event happened in the united states.
Additional Manufacturer Narrative
Investigation: checking the manufacturing charts of the removed components, no pre-existing anomaly was discovered in the items belonging to the same product codes and lot numbers as the devices involved in this event.This is the first and only complaint received on this lot numbers.We did not receive any additional information regarding this event, therefore we are unable to carry out further investigation.However, considering that: no pre-existing anomalies have been discovered by checking the manufacturing charts of the lot numbers of the items involved in this event.This is the first and only complaint received on these lot numbers.We have no evidence to consider the event as product related.Pms data: according to the available pms data, the revision rate of smr anatomic humeral bodies belonging to the family product code 1350.15.Xxx due to loosening is lower than 0.01% 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 final mdr.

• Brand Name: SMR SHOULDER
• Common Device Name: TRAUMA HUMERAL BODIES WITH LOCKING SCREW MEDIUM
• 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: 22458124
• Report Number: 3008021110-2025-00087
• Device Sequence Number: 8155722
• Product Code: KWT
• UDI-Device Identifier: 08033390002004
• UDI-Public: 08033390002004
• Combination Product (Y/N): N
• PMA/510(K) Number: K100858
• 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,Followup
• Report Date (Section B): 09/01/2025

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: 1350.15.010
• Device Lot Number: 2023593
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 09/02/2025
• 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