MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER SYSTEM; FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.22MM

Model Number	1304.15.220
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	03/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records (dhrs) and the sterilization charts for the involved lot numbers was performed and did not reveal any pre-existing anomaly.A final report will be submitted once the investigation has been completed.
Event or Problem Description
Revision surgery was performed on (b)(6) 2026, due to infection.During the revision surgery shoulder reverse configuration consisting of lima humeral components and djo glenoid components has been converted into an anatomic configuration composed by djo components only.Following pre-existing lima components have been explanted: smr cementless finned stem (pn 1304.15.220, lot.2220341, ster.(b)(6); smr humeral extension + 9 mm (pn 1352.15.001, lot.2429616, ster.(b)(6); finned reverse hum.Body 140° (pn 1352.15.051, lot.2516852, ster.(b)(6); smr rev.Liner retentive +6 mm (pn 1361.50.820, lot.24at4lp, ster.(b)(6).Surgery has been completed as intended.Previous surgery occurred on (b)(6) 2026.Patient is male, date of birth (b)(6) 1956.Event occurred in the united states.

• Brand Name: SMR SHOULDER SYSTEM
• Common Device Name: FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.22MM
• 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: 25134379
• Report Number: 3008021110-2026-00203
• Device Sequence Number: 9316284
• Product Code: HSD
• UDI-Device Identifier: 08033390000963
• UDI-Public: 8033390000963
• Combination Product (Y/N): N
• PMA/510(K) Number: K101263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 05/07/2026

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: 1304.15.220
• Device Lot Number: 2220341
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2026
• 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 Age: 69 YR
• Patient Sex: Male