MAUDE Adverse Event Report: Limacorporate S.p.A SMR Shoulder; Reverse Humeral Body for Elective Surgery

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	01/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Shoulder revision surgery due to septic loosening performed on (b)(6) 2025.Patient had a hybrid implant consisting of the following components (all removed because of loosening) and third-party components: smr cementl.Rev.Stem ø13 mm (part code 1308.15.134, lot number 1816629, sterilization (b)(4).Smr humeral extension + 9 mm (part code 1352.15.001, lot number 1918660, sterilization (b)(4).Smr reverse humeral body (part code 1352.15.010, lot number 1919690, sterilization (b)(4) smr reverse liner std d.40mm (part code 1365.50.810, lot number 19at18l, sterilization (b)(4).The baseplate and the glenosphere (which was unable to be removed) were third-party components.The patient was irrigated and debrided in a one stage infection procedure.A new 14x150 revision stem was trailed and implanted with a short reverse humeral body and +3-40 poly liner.Previous surgery took place on (b)(6) 2020.The patient is a male, date of birth (b)(6) 1964.The event happened in the united states.
Additional Manufacturer Narrative
Checking the manufacturing and sterilization charts of the components involved in the event, no pre-existing anomaly was found out on the items belonging to the same lot numbers.We will submit a final report as soon as the investigation is complete.

• Brand Name: SMR Shoulder
• Common Device Name: Reverse Humeral Body for Elective Surgery
• 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: 21459494
• Report Number: 3008021110-2025-00010
• Device Sequence Number: 18139157
• Product Code: PHX
• 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: 2020
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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: 1919690
• 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: 02/25/2025
• Supplement Report FDA Received Date: 09/18/2026
• 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