MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SYSTEM; SMR SYSTEM - METAL BACK LINER SMALL-R

Model Number	1377.50.005
Medical Device Problem Codes	Degraded (1153); Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Shoulder revision surgery performed on (b)(6) 2025, due to multiple complications, including suspected subscapularis failure, implant instability, polyethylene loading failure, polyethylene disruption, and baseplate failure.According to the information received, the patient initially underwent primary smr anatomic surgery in 2014.In 2022, after experiencing two falls, the patient consulted the surgeon but initially chose not to undergo revision surgery.The following components were involved in this case: smr uncemented glenoid #small-r (code: 1375.20.005, lot n.1400108, sterilization n.1400054) liner f.Metal back glenoid small-r (code: 1377.50.005, lot n.1313557, sterilization n.1300306).Sold in us.Smr humeral head ø44 mm (part code: 1322.09.440).Neutral adaptor taper standard (part code: 1330.15.270).Smr finned humeral body (part code: 1350.15.110).Smr cementless finned stem (part code: 1304.15.170).Bone screw ø6.5 h.20mm (part code: 8420.15.010).Bone screw ø6.5 h.25mm (part code: 8420.15.020).Patient details: female, 85 years old, bmi: 41.4 (pre-op, (b)(6) 2024).The exact implantation date of the above-listed components in 2014 was not provided by the complaint source.Additionally, we were informed that the finned stem (code: 1304.15.170) was not explanted.Event occurred in the united kingdom.
Additional Manufacturer Narrative
By checking the dhrs of lot.1400108 - ster.1400054 and lot.1313557- ster.1300306, no pre-existing anomaly was detected on the devices manufactured with these lot numbers involved.The explants were not returned to limacorporate for further analysis.Limacorporate received pre- operative x-rays of revision surgery and the photo of the explanted components.The available information and x-rays have been evaluated by a medical consultant.Following, the medical consultant comments: "the age of the patient is key: rotator cuff failure is the most likely reason for this dislocation and instability that led to revision.Very bold to try atsa at that age by the surgeon.There is no implant-related issue but this is a fateful course of events." based on the available information, we cannot determine with certainty the root cause of the event.Considering that: - the check of the device history records revealed no pre-existing anomalies in the involved lot numbers - the explanted devices were not returned to limacorporate for further investigation.- according to the medical consultant, rotator cuff failure is the most likely reason for this dislocation and instability that led to revision and the age of the patient is a related factor.There is no implant-related issue.We may conclude that the event is not product related.Pms data: according to limacorporate pms data the revision rate of smr anatomic prosthesis due to dislocation is around 0.14%.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 issue.Note: this is a combined initial-final mdr.

• Brand Name: SMR SYSTEM
• Common Device Name: SMR SYSTEM - METAL BACK LINER SMALL-R
• Manufacturer (Section D): LIMACORPORATE S.P.A; villanova di san daniele; via nazionale 52; udine 33038 ; IT 33038
• Manufacturer Contact: villanova di san daniele; via nazionale 52; udine
• MDR Report Key: 21708943
• Report Number: 3008021110-2025-00024
• Device Sequence Number: 10010686
• Product Code: KWS
• UDI-Device Identifier: 08033390272674
• UDI-Public: 08033390272674
• Combination Product (Y/N): N
• PMA/510(K) Number: K113254
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2025

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 Expiration Date: 10/01/2018
• Device Model Number: 1377.50.005
• Device Catalogue Number: 1377.50.005
• Device Lot Number: 1313557
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 03/27/2025
• Date Device Manufactured: 10/29/2013
• 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