MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; HUMERAL HEADS (COCRMO) DIA.42MM

Model Number	1322.09.420
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of manufacturing and sterilization records did not highlight any pre-existing non-conformity that could have contributed to reported issue.The manufacturer will submit a final report as soon as the investigation is completed.
Event or Problem Description
Revision surgery performed on (b)(6) 2026 due to shoulder dislocation.Previous surgery occurred on (b)(6) 2021, when the following anatomic assembly was implanted: finned stem dia16mm l80 (pn 1304.15.160), humeral body trauma short (pn 1350.15.030, lot 1508788, sterilization 2100166), adaptor taper neutral (pn 1330.15.270, lot 2013121, sterilization 2000263), humeral head dia 42mm (pn 1322.09.420, lor 1917287, sterilization 1900460), glenoid metal back small-r (pn 1375.21.005), liner for metal back small-r (pn 1377.50.005, lot 20at0xs, sterilization 2000235).After patient dislocation, the surgeon decided to perform a conversion to reverse configuration for stability.The above mentioned humeral body, adaptor taper, humeral head and liner for metal back were removed and replaced with humeral body reverse (pn 1352.14.010), retentive liner +6mm (pn 1361.50.820), connector lateralized+2mm small-r (pn 1374.15.312) and glenosphere dia36mm (pn 1374.09.111).Surgery was completed as intended.Patient is female, date of birth (b)(6) 1959.The event occurred in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: HUMERAL HEADS (COCRMO) DIA.42MM
• 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: 25297977
• Report Number: 3008021110-2026-00226
• Device Sequence Number: 21155760
• Product Code: KWT
• UDI-Device Identifier: 08033390001373
• UDI-Public: 8033390001373
• Combination Product (Y/N): N
• PMA/510(K) Number: K100858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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: 1322.09.420
• Device Lot Number: 1917287
• 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: 66 YR
• Patient Sex: Female