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

Model Number	1352.15.010
Medical Device Problem Codes	Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed on (b)(6) 2025 due to infection and scapular notching.Previous surgery occurred about 9-10 years before, and original prosthetic assembly consisted of baseplate, lateralized connector +4mm, glenosphere eccentric dia 40mm and smr humeral body reverse (part number 1352.15.010, lot unknown).During revision surgery the above-mentioned reverse humeral body was replaced with a new one.Surgery was completed as intended.The patient is male, date of birth (b)(6)1962.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: 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: 24018219
• Report Number: 3008021110-2026-00010
• Device Sequence Number: 21116339
• Product Code: PHX
• UDI-Device Identifier: 08033390002073
• UDI-Public: 8033390002073
• Combination Product (Y/N): N
• PMA/510(K) Number: K110598
• 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): 01/08/2026

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
• 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