MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; HUMERAL HEADS (COCRMO) DIA.48MM

Model Number	1322.09.480
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	04/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of manufacturing records did not identify any pre-existing anomaly relevant to the issue.The manufacturer will submit a final report as soon as the investigation is completed.
Event or Problem Description
Revision surgery was performed on (b)(6) 2026 due to continuous pain.Previous surgery was performed on (b)(6) 2025 to remove failed djo glenoid components re-establish shoulder functionality with a hemiarthroplasty consisting of: humeral body reverse (pn 1352.15.010, lot 2509312, sterilization (b)(4) adaptor 36mm for reverse body (pn 1352.15.200, lot 2307639, sterilization (b)(4) humeral head dia 48mm (pn 1322.09.480, lot 2410912, sterilization (b)(4).Original stem was left in place.Due to continuos pain and severe bone deficiency of patient anterior glenoid (temporary packed with bone graft during previous surgery), custom made implant (cmd 26-1040) has been requested for an augmented glenoid reverse configuration with coracoid support.Revision surgery to finally implant the custom made device has been successfully completed on (b)(6) 2026 (hereby reported): above mentioned humeral compoents have been removed and replaced with new humeral body reverse short (pn 1352.15.005) and reverse liner +3mm (pn 1360.50.815), while on the glenoid side the custom monoblock glenoid (pn 9618.14.20m - cmd 26-1040) with djo glenosphere (rsp glenoid head 36mm +2mm lateral offset) have been properly implanted.The patient is female, date of birth (b)(6) 1943.The event occurred in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: HUMERAL HEADS (COCRMO) DIA.48MM
• 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: 25297979
• Report Number: 3008021110-2026-00231
• Device Sequence Number: 21155762
• Product Code: KWT
• UDI-Device Identifier: 08033390274258
• UDI-Public: 8033390274258
• Combination Product (Y/N): N
• PMA/510(K) Number: K100858
• 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): 05/27/2026

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: 1322.09.480
• Device Lot Number: 2410912
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/27/2026
• 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: 82 YR
• Patient Sex: Female