MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; HUMERAL HEADS (COCRMO) - DIA.54MM H.18

Model Number	1322.09.541
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed on (b)(6) 2025 due to cuff failure.Previous surgery date is unknown, as well as complete assembly information of previous implant.Total shoulder arthroplasty was converted to a reverse shoulder arthroplasty stability due to post-operative rotator cuff tear.During revision the following components were explanted: smr humeral head d.54 h.18mm (part number 1322.09.541, lot unknown), smr finned humeral body (part number 1350.15.110), liner f.Met.Back glen.Standard (part number 1377.50.010).And replaced with reverse configuration components: connector and screw small std (part number 1374.15.310), glenosphere ecc dia 36mm (part number 1376.09.031), humeral body reverse short (part number 1352.15.005), retentive liner reverse std dia 36mm (part number 1360.54.811).Surgery was completed as intended.Patient is male, date of birth (b)(6) 1939.The event occurred in the united states.
Additional Manufacturer Narrative
Explanted components have been discarded therefore cannot be returned to manufacturer for identification and investigation.No review of manufacturing records for complained parts is therefore possible.The manufacturer will provide a final report as soon as the investigation is completed.

• Brand Name: SMR SHOULDER
• Common Device Name: HUMERAL HEADS (COCRMO) - DIA.54MM H.18
• 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: 24018206
• Report Number: 3008021110-2026-00008
• Device Sequence Number: 21130179
• Product Code: KWT
• UDI-Device Identifier: 08033390274432
• UDI-Public: 8033390274432
• Combination Product (Y/N): N
• PMA/510(K) Number: K161476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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): 01/07/2026

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: 1322.09.541
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2026
• 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 Sex: Unknown