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	Break (1069); Degraded (1153); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the first and only complaint registered on the involved lot number.A final report will be submitted after the conclusion of the investigation.
Event or Problem Description
Shoulder revision surgery occurred on (b)(6) 2024, due to successively increasing discomfort in the last two years with mechanical symptoms.Complaint source reported that during revision surgery liner f.Met.Back glen.Small-r (product code: 1377.50.005, lot.17at24t - ster.1800028) resulted luxated with broken pegs and parts of the base plate were worn down.The head of the top screw was almost completely gone.Pronounced metallosis and the massive metallosis was subcompletely cleaned.The bottom screw was very tight but could be unscrewed in its entirety without deformation.The head of the top screw was rundown and penetrates the upper hole of the standard plate.The baseplate was chiseled, and the top screw was unscrewed.The possibility of being able to implant a 360 was evaluated, but when trying to place the glenosphere the operator noticed that the upper screw had penetrated the cortex, and the construction was loose.The upper screw was removed, and a custom glenoid metal back was requested to limacorporate.Devices reported below were implanted during previous surgery performed on (b)(6) 2018, due to moderate glenohumeral osteoarthritis.· liner f.Met.Back glen.Small-r (product code: 1377.50.005, lot.17at24t - ster.1800028) · smr humeral head ø48 mm (product code: 1322.09.480, lot.1700267 - ster.1700049) · smr eccent.Adaptor taper long (product code: 1331.15.272, lot.1102076 - ster.1800100) · smr finned humeral body (product code: 1350.15.110, lot.1802875 - ster.1800105) · smr uncement.Glenoid #small-r (product code: 1375.20.005, lot.1806186 - ster.1800159 · bone screw ø6,5 h.25mm (product code: 8420.15.020, lot.1807674 - ster.1800117) · bone screw ø6,5 h.35mm (product code: 8420.15.050, lot.1808239 - ster.1800181) patient: female, 64 years old, bmi 25,83, active activity level.Event occurred in sweden.
Additional Manufacturer Narrative
The dhrs chart of for the involved lot number lot.17at24t - ster.(b)(4) did not highlight any pre-existing anomalies on the pieces manufactured with this lot number.This is the first and only complaint registered on the involved lot number.The devices explanted were not available for return, since these are all discarded by the hospital.Therefore, no physical analysis could be carried out.The following x-rays and ct were made available from the complaint source.· post-op previous surgery ((b)(6) 2018).· pre revision surgery ((b)(6) 2023).· post revision surgery ((b)(6) 2024).· ct-scan ((b)(6) 2018).The available information, x-rays and ct scan were evaluated by a medical consultant.Following, the medical consultant comments: "the first postop image 2018 shows an atsa with a very low positioned glenoid baseplate and a good degree of downward inclination.This seems to be an unfavorable implant position to start with.The next radiograph 2023 show a superiorly migrated humerus (superior decentering) which can be either due to rc failure or the consequence of the malpositioned glenoid component.This led to excentrical loading of the pe line, wear and eventually metallosis and loosening.This is a surgical error.No implant related issues to be observed." considering that: · the check of dhrs revealed no pre-existing anomalies in the involved lot number · the explanted devices were not returned to limacorporate for further investigation.· and according to the medical expert the event is mostly related to a surgical error.We may conclude that the event is not product related.Pms data: product family analysis: according to the relevant pms data, the revision rate of the liners belonging to the part codes 1377.50.005-1377.50.010- 1377.50.020-1377.50.030 due to dislocation/breakage is around (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 will continue monitoring the market to promptly detect any further similar issue.This is an mdr final report.
Event or Problem Description
Shoulder revision surgery occurred on (b)(6) 2024, due to successively increasing discomfort in the last two years with mechanical symptoms.Complaint source reported that during revision surgery liner f.Met.Back glen.Small-r (product code: 1377.50.005, lot.17at24t - ster.(b)(4)) resulted luxated with broken pegs and parts of the base plate were worn down.The head of the top screw was almost completely gone.Pronounced metallosis and the massive metallosis was subcompletely cleaned.The bottom screw was very tight but could be unscrewed in its entirety without deformation.The head of the top screw was rundown and penetrates the upper hole of the standard plate.The baseplate was chiseled, and the top screw was unscrewed.The possibility of being able to implant a 360 was evaluated, but when trying to place the glenosphere the operator noticed that the upper screw had penetrated the cortex, and the construction was loose.The upper screw was removed, and a custom glenoid metal back was requested to limacorporate.Devices reported below were implanted during previous surgery performed on (b)(6) 2018, due to moderate glenohumeral osteoarthritis.· liner f.Met.Back glen.Small-r (product code: 1377.50.005, lot.17at24t - ster.(b)(4)).· smr humeral head ø48 mm (product code: 1322.09.480, lot.1700267 - ster.(b)(4)).· smr eccent.Adaptor taper long (product code: 1331.15.272, lot.1102076 - ster.(b)(4)).· smr finned humeral body (product code: 1350.15.110, lot.1802875 - ster.(b)(4)).· smr uncement.Glenoid #small-r (product code: 1375.20.005, lot.1806186 - ster.(b)(4)).· bone screw ø6,5 h.25mm (product code: 8420.15.020, lot.1807674 - ster.(b)(4)).· bone screw ø6,5 h.35mm (product code: 8420.15.050, lot.1808239 - ster.(b)(4)).Patient: female, 64 years old, bmi 25,83, active activity level.Event occurred in sweden.

• Brand Name: SMR SYSTEM
• Common Device Name: SMR SYSTEM - METAL BACK LINER SMALL-R
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 20641114
• Report Number: 3008021110-2024-00097
• Device Sequence Number: 7471195
• 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 Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1377.50.005
• Device Catalogue Number: 1377.50.005
• Device Lot Number: 17AT24T
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 06/20/2025
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown