MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER; REVERSE HUMERAL BODY

Model Number	1352.15.010
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	02/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Checking the manufacturing and sterilization charts of the components involved in the event, no pre-existing anomaly was discovered in the items belonging to the same part code and lot number as the devices removed.We will submit a final mdr as soon as the investigation is complete.
Event or Problem Description
Shoulder revision surgery performed on (b)(6) 2025, due to infection.All the following components were removed: smr cementless finned stem (part code 1304.15.140, lot number 2211467, sterilization (b)(4), smr reverse humeral body (part code 1352.15.010, lot number 2012985, sterilization (b)(4), smr reverse liner +3mm d.40mm (part code 1365.50.815, lot number 23at023, sterilization (b)(4), smr glenosphere ø 40mm (part code 1374.09.121, lot number 2321556, sterilization (b)(4), smr small/std connector +2 (part code 1374.15.322, lot number 2213447, sterilization (b)(4), smr glenoid peg tt s/std #m (part code 1375.14.662, lot number 1908192, sterilization (b)(4), smr glenoid baseplate standard (part code 1375.15.610, lot number 1908455, sterilization (b)(4), bone screw ø6,5 h.30mm (part code 8420.15.030, lot number 2327434, sterilization (b)(4), bone screw ø6,5 h.35mm (part code 8420.15.040, lot number 2302588, sterilization (b)(4).The devices removed were replaced by different components.Previous surgery took place on (b)(6) 2024.The patient is a female, date of birth february (b)(6) 1961.The event happened in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: REVERSE HUMERAL BODY
• 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: 21770685
• Report Number: 3008021110-2025-00027
• Device Sequence Number: 8235998
• Product Code: KWS
• UDI-Device Identifier: 08033390002073
• UDI-Public: 08033390002073
• Combination Product (Y/N): N
• PMA/510(K) Number: K110598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 04/04/2025

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: 1352.15.010
• Device Lot Number: 2012985
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2025
• 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