MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; REVERSE LINERS 36MM (UHMWPE) +6MM

Model Number	1360.50.820
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of manufacturing and sterilization records did not identify any pre-existing anomaly or non-conformity that could have contributed to reported issue.The manufacturer will provide a final report as soon as the investigation is completed.
Event or Problem Description
Revision surgery was performed on (b)(6) 2025 due to glenoid components failure.Previous surgery was performed on (b)(6) 2023 when the original assembly, consisting of smr humeral components coupled with zimmerbiomet vrs custom glenoid, was implanted.During revision the surgeon removed the failed glenoid components, and replaced the smr reverse humeral body (pn 1352.15.010, lot 2222575, sterilization, (b)(4) and smr reverse liner +6 mm (pn 1360.50.820, lot 19at06n, sterilization (b)(4)) with adaptor taper neutral (pn 1330.15.270), humeral body trauma long (pn 1350.15.020) and cta head dia54mm (pn 1323.09.540) to convert the reverse prosthesis to an anatomic configuration.Surgery was completed as intended.Patient is male, date of birth (b)(6) 1954.The event occurred in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: REVERSE LINERS 36MM (UHMWPE) +6MM
• 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: 24362075
• Report Number: 3008021110-2026-00110
• Device Sequence Number: 9794995
• Product Code: PHX
• UDI-Device Identifier: 08033390080637
• UDI-Public: 8033390080637
• Combination Product (Y/N): N
• PMA/510(K) Number: K110598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 02/17/2026

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: 1360.50.820
• Device Lot Number: 19AT06N
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2026
• 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