MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; FINNED HUMERAL BODIES WITH LOCKING SCREW

Model Number	1350.15.110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Implant Pain (4561); Medical device site infection (4845)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation.Review of manufacturing and sterilization records did not identify any pre-existing anomaly or nonconformity that may have contributed to reported issue.Complaint database review did not highlight any further similar issues on involved batches from the market.From follow-up communication with sales representative it was learned that surgeon opted for a reverse configuration because it was deemed better for the patient and the glenosphere that was implanted for reverse configuration in revision was from a different manufacturer (tornier).No further information is available regarding the nature of infection since it is not known if cultures have been performed and in case which is their outcome, nor the explanted components will be returned to manufacturer, therefore no further investigation is possible to determine root cause of this event.Based on all gathered information and considering that no deviation in manufacturing and sterilization records has been found, the manufacturer has no evidence to consider this event as product related.Pms data according to the available pms data, the revision rate of smr humeral bodies belonging to the family product codes 1350.15.Xxx due to infection is around 0.03%.Based on the analysis performed and according to the relevant pms data, no corrective actions is required for this specific case.The manufacturer will continue monitoring the market to promptly detect any further similar issue.Note: this is a combined initial-final mdr.
Event or Problem Description
Revision surgery performed on (b)(6) 2025 due to pain and suspected infection.Patient was experiencing pain, surgeon suspected infection.Following components were removed during surgery: - smr humeral head d.46 h.15mm (part number 1321.09.461, lot number 2200510, sterilization 2200067), - smr ecc.Adaptor taper standard (part number 1330.15.274, lot number 2013120, sterilization 2000264), - smr finned humeral body (part number 1350.15.110, lot number 2213920, sterilization 2200221) - cemented glenoid 3 pegs small (part number 1379.50.020, lot number 20at5eg, sterilization 2200049).Reverse configuration (reverse humeral body part number 1352.15.005, extension for humeral reverse body part number 1352.15.001, retentive liner part number 1361.50.815) was implanted during revision.Previous surgery date is unknown.Patient is male, date of birth (b)(6)1955.The event occurred in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: FINNED HUMERAL BODIES WITH LOCKING SCREW
• 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: 23693253
• Report Number: 3008021110-2025-00153
• Device Sequence Number: 9152839
• Product Code: HSD
• UDI-Device Identifier: 08033390002035
• UDI-Public: 8033390002035
• Combination Product (Y/N): N
• PMA/510(K) Number: K101263
• 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): 12/02/2025

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: 1350.15.110
• Device Lot Number: 2213920
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2025
• 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