MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER SYSTEM; HUMERAL HEADS (COCRMO) - DIA.44MM H.14

Model Number	1321.09.441
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explanted components have been discarded therefore cannot be returned to manufacturer for identification and analysis.Review of production records for complained components cannot be performed as lot number is unknown.The manufacturer will submit a final report as soon as the investigation is completed.
Event or Problem Description
Revision surgery has been performed on (b)(6) 2026 for unknown reason.Previous surgery is unknown, as well as complete product information of original implant.During revision surgery the original humeral haed, adaptor taper and liner for metal back were replaced with new ones (pn 1321.09.441, 1330.15.270, 1377.50.005 respectively).Surgery was completed as intended.Patient is female, date of birth (b)(6)1960.Event occurred in the united states.

• Brand Name: SMR SHOULDER SYSTEM
• Common Device Name: HUMERAL HEADS (COCRMO) - DIA.44MM H.14
• 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: 24603380
• Report Number: 3008021110-2026-00147
• Device Sequence Number: 8384342
• Product Code: KWT
• UDI-Device Identifier: 08033390116268
• UDI-Public: 8033390116268
• Combination Product (Y/N): N
• PMA/510(K) Number: K161476
• 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): 03/13/2026

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: 1321.09.441
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2026
• 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: 65 YR
• Patient Sex: Female