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

Model Number	1322.09.540
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	03/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explanted components have been discarded therefore cannot be returned to manufacturer for identification and analysis.No review of manufacturing records for complained parts can be performed either since lot number is unknown.No x-rays nor pictures of explanted components were provided either.From follow-up communication with complaint source it was confirmed that no further information regarding the case can be retrieved, therefore no further root cause investigation is possible.Taking into account the involved product family smr shoulder, no adverse trend has been identified for reported issue in the last year.According to investigation carried out, no corrective action is needed for this event.The manufacturer will continue monitoring the market in order to detect any similar event.
Event or Problem Description
Revision surgery was performed on (b)(6) 2025 due to irreparable rotator cuff tear.Previous surgery is unknown, as well as complete information about original implant.During revision the surgeon explanted the pre-existing anatomic components: - liner for metal back glenoid small (part number 1377.50.020), - smr finned humeral body (part number 1350.15.110), - smr eccentrical adaptor taper (part number 1330.15.272), - smr humeral head dia54mm (part number 1322.09.540), and converted the prosthesis to a reverse configuration implanting a lateralized +2mm connector (part number 1374.15.322), an eccentrical glenosphere dia40mm (part number 1376.09.041), a reverse humeral body (part number 1352.15.010) and reverse liner +3mm dia40 (part number 1365.50.815).Surgery was completed as intended.Patient is male, date of birth (b)(6) 1968, weight 365lbs.The event occurred in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: HUMERAL HEADS (COCRMO) DIA.54MM
• 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: 24176355
• Report Number: 3008021110-2026-00038
• Device Sequence Number: 9979777
• Product Code: HSD
• UDI-Device Identifier: 08033390274319
• UDI-Public: 8033390274319
• Combination Product (Y/N): N
• PMA/510(K) Number: K100858
• 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): 01/26/2026

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: 1322.09.540
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2026
• 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