MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SYSTEM; SMR SYSTEM - HUMERAL HEAD DIA. 46 MM

Model Number	1322.09.460
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: checking the manufacturing charts of the smr humeral heads belonging to the part code: 1322.09.460 and lot number: 2402987, no pre-existing anomaly was discovered on the (b)(4) items manufactured with the lot number above mentioned.The manufacturer will submit the final mdr as soon as the investigation is complete.
Event or Problem Description
Upcoming shoulder revision surgery due to rotator cuff tear.Patient underwent uneventful stemless total shoulder arthroplasty on (b)(6) 2024.Post operatively, the patient was noted to have recurrent shoulder pain and weakness, diagnosed with a rotator cuff tear.The revision surgery has not been performed yet.The patient has the following components currently implanted: smr humeral head ø46 mm (part code: 1322.09.460, lot number: 2402987, sterilization: 2400067).Tt hybrid cem.Glenoid small (part code: 1379.59.110, lot number: 2405576, sterilization: 2400060).Smr stemless - 2mm ecc.Adaptor (part code: 1335.15.202, lot number: 2419850, sterilization 2400181).- smr stemless - steml.Core #m (part code: 1355.14.135, lot number: 2332476, sterilization 2400065).The patient is a male, date of birth on (b)(6) 1960.The event happened in the united states.

• Brand Name: SMR SYSTEM
• Common Device Name: SMR SYSTEM - HUMERAL HEAD DIA. 46 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: 22114664
• Report Number: 3008021110-2025-00065
• Device Sequence Number: 4109836
• Product Code: KWT
• UDI-Device Identifier: 08033390274234
• UDI-Public: 08033390274234
• Combination Product (Y/N): N
• PMA/510(K) Number: K100858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/30/2025

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: 1322.09.460
• Device Lot Number: 2402987
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/30/2025
• 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