MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER SYSTEM; HUMERAL HEADS (COCRMO) DIA.48MM

Model Number	1322.09.480
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	02/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explanted component has been discarded therefore cannot be returned to manufacturer for analysis.Review of production records for complained component has been performed and did not highlight any anomaly.The manufacturer will submit a final report as soon as the investigation is completed.
Event or Problem Description
Revision surgery was performed on (b)(6) 2026 to convert an anatomic configuration into a reverse due to rotator cuff failure.Original surgery occurred on (b)(6) 2025.During the revision, pre-existing following components: cemented glenoid 3 pegs std (pn 1379,50,010, lot.21at03r, ster.(b)(4), humeral head dia.48mm (pn 1322.09.480, lot.2436382, ster.(b)(4), adaptor taper eccentrical 2mm (pn 1330.15.272, lot.2506202, ster.(b)(4), finned stem dia.19mm l.80mm (pn 1304.15.190, lot.2434110, ster.(b)(4), humeral body trauma medium (pn 1350.15.010, lot.2504857, ster.(b)(4).Have been explanted and replaced with: humeral body reverse short (pn 1325.15.005); reverse liner retentive +6mm dia.40 mm (pn 1365.50.821); connector + screw small-r (pn 1374.15.305); glenosphere dia.40mm (pn 1374.09.121); metal back glenoid small-r (pn 1375.21.005).Minimal bone loss for the glenoid was confirmed during revision that was completed as intended.Patient is female, date of birth (b)(6) 1958.The event occurred in the united states.

• Brand Name: SMR SHOULDER SYSTEM
• Common Device Name: HUMERAL HEADS (COCRMO) DIA.48MM
• 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: 24763588
• Report Number: 3008021110-2026-00164
• Device Sequence Number: 18458412
• Product Code: HSD
• UDI-Device Identifier: 08033390274258
• UDI-Public: 8033390274258
• Combination Product (Y/N): N
• PMA/510(K) Number: K100858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 04/02/2026

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: 1322.09.480
• Device Lot Number: 2436382
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2026
• 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: 67 YR
• Patient Sex: Female