MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; REVERSE LINER DIA.36MM, +6MM

Model Number	1360.54.820
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of manufacturing and sterilization records did not highlight any pre-existing anomaly or non-conformity relevant to the issue.Complaint database review revealed no further complaints for involved batch of liner from the market.From follow-up communication it was learned that massive bone loss and compromised tissues pre-existed due to previous fracture, shoulder prosthesis was positively tested for stability at the end of previous surgery and patient followed proper rehab indications.No x-rays were available to further investigate and part was discarded.At follow-up appointment patient confirmed no further issues with the prosthesis.Taking into account all the above, the manufacturer has no evidence to consider the event as product related.The most likely root cause of the event is related to pre-existing critical patient bone and soft tissue condition that did not improve during healing process, but it cannot be confirmed since patient x-rays are not available.According to the available pms data, the revision rate of smr reverse liners belonging to the family product codes 1360.50/54.Xxx, 1361.50.Xxx and 1365.50/54.Xxx due to instability is around 0.04%.Based on the analysis performed and according to the relevant pms data, no corrective actions is required for this specific case.The manufacturer will continue monitoring the market to promptly detect any further similar issue.Note: this is a combined initial-final mdr.
Event or Problem Description
Revision surgery was performed on (b)(6) 2026 due to shoulder instability.The patient had a fracture of the proximal humerus that was initially treated with an open reduction and internal fixation (surgical procedure to repair severe bone fractures using hardwares like screws, plates and/or rods).After a failure of the orif, on (b)(6) 2026 the surgeon opted to perform a reverse arthroplasty using a combination of altivate reverse glenoid components (from other manufacturer) and smr system on the humeral side, consisting of: - revision stem cemented dia 13mm h 210 (pn 1309.15.138, lot 1917114, sterilization (b)(4)), - 140° finned reverse humeral body (pn 1352.15.051, lot 2519456, sterilization (b)(4)), - reverse liner 36mm +6mm (pn 1360.54.820, lot 24at117, sterilization (b)(4)).During healing process patient experienced some shoulder instability.During revision the surgeon removed the pre-existing liner and replaced it with an extension for humeral reverse body (pn 1352.15.001) and a retentive liner reverse dia36mm +6mm (pn 1360.54.821) to increase tissue tension.Also, the glenosphere from other manufacturer was replaced with new one.Surgery was completed as intended.The patient is male, date of birth (b)(6)1949.The event occurred in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: REVERSE LINER DIA.36MM, +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: 24638405
• Report Number: 3008021110-2026-00149
• Device Sequence Number: 9760851
• Product Code: PHX
• UDI-Device Identifier: 08033390268219
• UDI-Public: 8033390268219
• 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): 03/17/2026

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: 1360.54.820
• Device Lot Number: 24AT117
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2026
• 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: 76 YR
• Patient Sex: Male