MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; REVERSE LINER DIA.36MM, STANDARD

Model Number	1360.54.810
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	05/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of manufacturing and sterilization records did not hihglight any pre-existing anomaly or non-conformity possibly contributing to reported issue.The manufacturer will submit a final report as soon as the investigation is completed.
Event or Problem Description
Revision surgery was performed on (b)(6) 2026 due to infection.Pre-existing smr reverse liner std 36mm (pn 1360.54.810, lot 25at37t, sterilization 2500177) originally implanted on (b)(6) 2026 was removed and replaced with a new one.Surgery was completed as intended.Patient is female, date of birth (b)(6) 1954.The event occurred in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: REVERSE LINER DIA.36MM, STANDARD
• 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: 25519177
• Report Number: 3008021110-2026-00248
• Device Sequence Number: 10553680
• Product Code: PHX
• UDI-Device Identifier: 08033390268134
• UDI-Public: 8033390268134
• Combination Product (Y/N): N
• PMA/510(K) Number: K220792
• 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): 06/16/2026

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: 1360.54.810
• Device Lot Number: 25AT37T
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2026
• 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: 72 YR
• Patient Sex: Female