MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER SYSTEM; REVERSE HUMERAL BODY FOR ELECTIVE SURGERY

Model Number	1352.15.010
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of production records for complained component has been performed and did not highlight any pre-existing anomaly nor non-conformity.A final report will be submitted as soon as the investigation is completed.
Event or Problem Description
Revision surgery hereby reported has been performed on (b)(6) 2026, due to unknown reasons.Patient was originally implanted with smr reverse prosthesis.Original prosthetic assembly consisted of baseplate, lateralized connector +4 mm, glenosphere eccentric dia 40 mm and smr humeral body reverse (part number 1352.15.010, lot unknown).9/10 years later, first revision surgery occurred ((b)(6) 2025) due to infection: humeral body has been explanted and replaced with a new one (complaint associated to mfr # 3008021110-2026-00010).On (b)(6) 2026, hereby reported second revision surgery has been performed and pre-existing humeral body (pn 1352.15.010, lot.2511798, ster.2500105) and glenoid components has been explanted and replaced with the following: 140° humeral body finned reverse (pn 1352.15.051); reverse liner + 3 mm dia 40 mm (pn 1365.50.815); glenosphere eccentrical dia 40 mm (pn 1376.09.041); connector + screw (pn 1374.15.305); tt baseplate (pn 1375.15.305); bone screw (pn 8420.15.050); bone screw (pn 8420.15.030).Patient is male, date of birth (b)(6) 1962.Event occurred in the united states.

• Brand Name: SMR SHOULDER SYSTEM
• Common Device Name: REVERSE HUMERAL BODY FOR ELECTIVE SURGERY
• 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: 25278965
• Report Number: 3008021110-2026-00241
• Device Sequence Number: 9568178
• Product Code: PHX
• UDI-Device Identifier: 08033390272568
• UDI-Public: 8033390272568
• Combination Product (Y/N): N
• PMA/510(K) Number: K110598
• 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): 05/26/2026

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: 1352.15.010
• Device Lot Number: 2511798
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2026
• 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 Age: 63 YR
• Patient Sex: Male