MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; REVERSE LINERS 36MM (UHMWPE) +3MM

Model Number	1360.50.815
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed on (b)(6) 2026 due to shoulder instability.Previous surgery is unknown, as well as complete product information of original implant.During revision the pre-existing smr reverse liner (pn (b)(4)), humeral extension +9mm (pn 1352.15.001), connector small (pn 1374.15.305) and glenosphere dia36mm (pn 1374.09.111) were removed and replaced with new connector, glenosphere eccentrical dia40mm (pn 1376.09.041), humeral extension and reverse liner retentive +6mm dia40mm (pn 1365.50.821), to increase the assembly thickness.Surgery was completed as intended.Patient is male, date of birth (b)(6) 1957.The event occurred in the united states.
Additional Manufacturer Narrative
Explanted device was discarded, therefore not available for identification and analysis.No review of manufacturing records can be performed since lot number is unknown.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) +3MM
• 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: 24813221
• Report Number: 3008021110-2026-00169
• Device Sequence Number: 9594215
• Product Code: PHX
• UDI-Device Identifier: 08033390273602
• UDI-Public: 8033390273602
• Combination Product (Y/N): N
• PMA/510(K) Number: K110598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/08/2026

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: 1360.50.815
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2026
• 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: 68 YR
• Patient Sex: Male