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

Model Number	1360.50.820
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Loose body in joint (4926)
Date of Event	01/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed on (b)(6) 2026 due to disassembly of components.Previous surgery was performed on (b)(6) 2025 and following components were implanted: smr reverse liner + 6 mm (part number: 1360.50.820, lot.24at5p8, sterilization n.2500009).Smr connector small std (part number: 1374.15.310, lot: 2500907, sterilization n.2500027).Smr glenosphere ø 36mm (part number: 1374.09.111, lot: 2506966, sterilization n.2500066).Smr metal-back glenoid small (part number: 1375.21.020, lot: 2435106, sterilization n.2500053).Smr cementless finned stem (part number: 1304.15.210, lot: 2102161, sterilization n.2100078).Some months after original surgery the above-mentioned reverse poly liner was found loose.During revision surgery liner was explanted and replaced with a new one from same lot.Surgery was completed as intended.Patient is a male, date of birth on (b)(6) 1940.The event occurred in unites states.
Additional Manufacturer Narrative
Explanted component was discarded therefore not available for testing.Review of manufacturing and sterilization records did not highlight any pre-existing non conformity on the involved lot relevant to the issue.From follow up communication with sales representative it was learned that loose liner was detected during revision surgery but no indication of component damage was reported by surgeon.No pictures of explanted component was shared to confirm its condition and x-rays were not made available.No issues during original surgery were reported either.The manufacturer will submit a final report as soon as the investigation is completed.

• 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: 24442723
• Report Number: 3008021110-2026-00124
• Device Sequence Number: 10364038
• Product Code: PHX
• UDI-Device Identifier: 08033390273619
• UDI-Public: 8033390273619
• Combination Product (Y/N): N
• PMA/510(K) Number: K110598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 02/25/2026

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: 24AT5P8
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/25/2026
• 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: 85 YR
• Patient Sex: Male