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

Model Number	1360.54.810
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery occurred on (b)(6) 2026, due to instability.Original surgery occurred on (b)(6) 2025, and shoulder prosthesis consisting of djo altivate reverse components only has been implanted.After failure of djo humeral implant, first revision surgery for this patient was performed on (b)(6) 2026, and following lima reverse humeral components were implanted: cementless finned stem l.80mm (pn 1304.15.180, lot.22523308, ster.(b)(4)) 140° humeral body reverse (pn 1352.15.011, lot.2525679, ster.(b)(4) reverse liner std dia.36 mm (pn 1360.54.810, lot.24at3aq, ster.(b)(4) second revision surgery, hereby reported, occurred on (b)(6) 2026 due to instability.Above-mentioned reverse liner and humeral body were removed and replaced with new humeral body (pn 1352.15.011) and reverse liner std dia.40 mm (pn 1365.54.811).Pre-existing djo glenosphere dia36mm was also replaced with a bigger one (dia40mm).Surgery was completed as intended.Patient is male, date of birth (b)(6)1963.The event occurred in the united states.
Additional Manufacturer Narrative
Revie wof manufacturing records for involved batches did not highlight any pre-existing anomaly or non-conformity relevant to the issue.The manufacturer will submit a final report as soon as the investigation is completed.

• 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: 25275494
• Report Number: 3008021110-2026-00218
• Device Sequence Number: 15874476
• 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): 05/26/2026

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: 24AT3AQ
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2026
• 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: 63 YR
• Patient Sex: Male