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	02/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed on (b)(6) 2025, due to infection.The following reverse components previously implanted was removed and replaced by cta hemi-arthroplasty: smr reverse humeral body (part code 1352.15.010, lot number 1600868, sterilization (b)(4).Smr reverse liner +6 mm (part code 1360.50.820, lot number 15at1sq, sterilization (b)(4).Smr glenoid peg tt small-r #m (part code 1375.14.652, lot number 1518555, sterilization (b)(4).Smr glenoid baseplate small-r (part code 1375.15.605, lot number 1517810, sterilization (b)(4).Smr glenosphere ø36mm small-r (part code 1376.09.025, lot number 1604615, sterilization (b)(4).Previous surgery took place on (b)(6) 2016.The patient is a female, date of birth (b)(6) 1947.The event happened in the united states.
Additional Manufacturer Narrative
Checking the manufacturing and sterilization chart of the components involved in the event, no pre-existing anomaly has been discovered in the items belonging to the same lot numbers and the removed devices.We will submit the final mdr as soon as the investigation is complete.

• 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: 21661889
• Report Number: 3008021110-2025-00017
• Device Sequence Number: 8647457
• Product Code: KWS
• UDI-Device Identifier: 08033390002073
• UDI-Public: 08033390002073
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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: 1352.15.010
• Device Lot Number: 1600868
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: 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: 03/21/2025
• Supplement Report FDA Received Date: 10/01/2026
• 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 Sex: Unknown