MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SYSTEM; SMR SYSTEM - FINNED STEM DIA. 11 MM L. 60 MM

Model Number	1304.15.110
Medical Device Problem Codes	Failure to Osseointegrate (1863); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Shoulder revision surgery performed on (b)(6) 2025, due to loosening of the smr cementless mini stem (product code: 1304.15.110, lot#: 2408106 - ster.2400113).According to the received information, the stem did not have good fixation proximally, more than likely as a result of the primary implant that was due to a fracture.It was also reported that the patient presented of complaining of pain, and x-rays showed what appeared to be bone resorption and it was determined that the stem was loose.The stem along with all other stem-related parts were extracted, in details: smr cementless mini stem (product code: 1304.15.110, lot#: 2408106 - ster.2400113).Smr humeral extension + 9 mm (product code: 1352.15.001, lot#: 2416019 - ster.2400149).Smr reverse finned humeral body (product code: 135215050, lot#: 2009741 - ster.2000208).Smr reverse liner + 3 mm (product code: 136050815, lot#: 23at248 - ster.2300197).The doctor then implanted competitor's humeral devices.Previous surgery on (b)(6) 2024.Patient is a female, 60 years old.No other clinical data are available.Event happened in the us.
Additional Manufacturer Narrative
Checking the dhrs of the involved lot#: 2408106, no pre-existing anomaly was found on the (b)(4) devices manufactured with that lot#.According to our records, this is the only complaint received on this lot#.Device analysis: devices involved were not returned to limacorporate for further analysis.No additional details were available on this event, specifically pre-operative x-rays weren't accessible.Based on the very few information received, we are not able to further investigate the root cause of the event.The check of manufacturing charts highlighted no anomalies on the components manufactured with the involved lot#: 2408106.According to the information received, the stem did not have good fixation proximally possibly as a result of the primary implant that was due to a fracture.The event is not product related.Pms data: according to limacorporate pms data, the revision rate of smr cementless stems - belonging to the product codes: 1304.15.Xxx - due to cuff failure is (b)(4).Based on the root cause analysis performed and according to the relevant pms data, no corrective actions required for this specific case.Limacorporate continues monitoring the market to promptly detect any similar issue.Note: this is a combined initial-final mdr.

• Brand Name: SMR SYSTEM
• Common Device Name: SMR SYSTEM - FINNED STEM DIA. 11 MM L. 60 MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 22104980
• Report Number: 3008021110-2025-00048
• Device Sequence Number: 15507981
• Product Code: HSD
• UDI-Device Identifier: 08033390270694
• UDI-Public: 08033390270694
• Combination Product (Y/N): N
• PMA/510(K) Number: K101263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/29/2025

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: 1304.15.110
• Device Catalogue Number: 1304.15.110
• Device Lot Number: 2408106
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/29/2025
• 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: Other
• Patient Sex: Unknown