MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SYSTEM; SMR SYSTEM - GLENOSPHERE ECCENTRICAL DIA. 36 MM

Model Number	1376.09.031
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Checking the manufacturing charts of the components involved with lot number: 2111077 and 19at0tk, no pre-existing anomalies were found in the pieces manufactured with the lot number involved.This is the first and only complaint received about the involved lot numbers: 2111077 and 19at0tk.The explanted devices were not returned for further inspection to limacoporate.The pre-operative and post-operative x-rays of both surgeries were provided by the complaint source.The available information and the x-rays were evaluated by a medical consultant and hereby his comment on the event: "after first implantation the radiographs show a malpositioned glenoid component, looks like axioma with bonegraft, very divergent screws.The subsequent images show upward migration and loosening of the metalback.It started with a rather normal bone deformity before that.Overall, it looks suspicious for surgical errors, such as improper baseplate fixation to me.The subsequent revision with explantation of glenoid parts and the metaphyseal part to prepare for promade custom-made glenoid, is unremarkable.The radiograph post promade implantation shows a fractures greater tuberosity.This is either due to surgical error during revision or trauma immediately postop., which we don't know.This than is a reason for the further described dislocations, because the dislocated greater tuberosity is a lever to the posterior glenoid during external rotation and abduction so again, suspicion for surgical error.There is no sign for implant-related failure, but either surgical mistake or fateful course of events." in conclusion, considering that: the check of manufacturing charts highlighted no anomalies on lot numbers: 2111077 and 19at0tk.According to the medical consultant "it looks suspicious for surgical errors, such as improper baseplate fixation".The event was not product related, rather a surgical-related factor could have contributed to the dislocation.Pms data: according to limacorporate pms data, revision rate of smr reverse due to dislocation is nearly 0,15%.Based on the root cause analysis performed and according to the relevant pms data, no corrective actions required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issues.Note - this is an initial - final mdr.
Event or Problem Description
Revision surgery was performed on (b)(6) 2023, for an smr reverse implant due to dislocation.The previous surgery had taken place on (b)(6) 2022.After several x-rays confirmed dislocation, radiolucency, and implant turned, a promade case was opened and in the first stage, the following explants were removed: smr eccent.Glenosphere ø 36mm (code 1376.09.031, lot n.2111077, ster.N.(b)(4), smr reverse liner + 6 mm (code 1360.50.020, lot n.19at0tk, ster.N.(b)(4), smr reverse humeral body short (code 1352.15.005, lot n.2107182, ster.N.(b)(4), smr connector small r (code 1374.15.305, lot n.19at0tk, ster.N.(b)(4), smr glenoid peg tt small-r #xl (code 1375.14.654, lot n.1907801, ster.N.(b)(4), smr glenoid baseplate small-r (code 1375.15.650, lot n.2111129, ster.N.(b)(4), bone screw ø6,5 h.25mm (code 8420.15.020, lot n.2124330, ster.N.(b)(4), bone screw ø6,5 h.30mm (code 8420.15.030, lot n.2023138, ster.N.(b)(4), bone screw ø6,5 h.40mm (code 8420.15.050, lot n.2016867, ster.N.(b)(4), bone screw ø6,5 h.40mm (code 8420.15.050, lot n.2016867, ster.N.(b)(4).Patient: female, dob: (b)(6) 1964.The same patient underwent another revision surgery performed on (b)(6) 2025, due to dislocation of an smr reverse products in combination with promade components.For this event another complaint with reference (b)(4) has been registered (mdr report number: 3008021110-2025-00082).Event happened in united kingdom.

• Brand Name: SMR SYSTEM
• Common Device Name: SMR SYSTEM - GLENOSPHERE ECCENTRICAL DIA. 36 MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; san daniele del friuli
• MDR Report Key: 22370032
• Report Number: 3008021110-2025-00083
• Device Sequence Number: 20839485
• Product Code: KWS
• UDI-Device Identifier: 08033390272339
• UDI-Public: 08033390272339
• Combination Product (Y/N): N
• PMA/510(K) Number: K163397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 07/01/2025

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: 1376.09.031
• Device Catalogue Number: 1376.09.031
• Device Lot Number: 2111077
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 07/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown