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

Model Number	1322.09.420
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	05/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed on (b)(6) 2026 due to cuff failure.Previous surgery is unknown, as well as complete product information of original assembly.In subsequent years, the patient experienced subscapularis failure requiring revision.During the surgery to address the subscapularis, the surgeon decided to replace the existing 42mm humeral head (pn 1322.09.420) with adaptor taper +4mm (pn 1330.15.274) with a smaller one (40mm h13 eccentrical 2mm humeral head, pn 1321.09.402).The pre-existing trauma humeral body #medium (pn 1350.15.010) has also been replaced with a short one (pn 1350.15.030).Subscapularis was repaired; assembly was reduced in size and surgery was completed as intended.Patient is female, date of birth (b)(6) 1948.The event occurred in the united states.
Additional Manufacturer Narrative
Explanted components were discarded therefore are not available for identification and investigation.No review of manufacturing records can be performed since lot number is unknown.Pre-op x rays were shared with medical expert who confirmed that the event is a clear case of rotator cuff failure over time (of unknown duration) which is the most frequent reason for revision of an anatomic total shoulder arthroplasty.The radiographs show a well seated anatomical stem but there are signs of overstuffing: center of rotation of the reconstructed joint is clearly medially displaced, indicating overstuffing of the joint.This would add stress to the natural course of rotator cuff failure over time.The manufacturer will submit a final report as soon as the investigation is completed.

• 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: 25680177
• Report Number: 3008021110-2026-00255
• Device Sequence Number: 4707647
• 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 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): 07/01/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2026
• 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: 78 YR
• Patient Sex: Female