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

Model Number	1377.50.010
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Implant Pain (4561)
Date of Event	09/27/2024
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
Revision shoulder surgery on (b)(6) 2024 due to pain, loss of range of motion of shoulder and liner wear.Previous surgery performed on (b)(6) 2023.The patient reported squeaking of the prosthesis since (b)(6) 2024 during certain movements, which intensified with increased pain.The following devices were replaced during revision: · liner f.Met.Back glen.Standard (product code: 1377.50.010, lot.22at1ym - ster.(b)(4)) - sold in us · smr humeral head ø48 mm (product code: 1322.09.480 , lot.2120289 - ster.(b)(4)) - sold in us · smr uncement.Glenoid # std (product code: 1375.20.010, lot.2309307 - ster.(b)(4)) - not sold in us · bone screw ø6,5 h.35mm (product code: 8420.15.040, lot: 2322192 - ster.(b)(4)) - sold in us · bone screw ø6,5 h.35mm (product code: 8420.15.040, lot: 2322192 - ster.(b)(4)) - sold in us patient: male, 66 years old, approximate height (m): 1.86, approximate weight (kg): 87.Event occurred in germany.
Event or Problem Description
Revision shoulder surgery on (b)(6) 2024 due to pain, loss of range of motion of shoulder and liner wear.Previous surgery performed on (b)(6) 2023.The patient reported squeaking of the prosthesis since (b)(6) 2024 during certain movements, which intensified with increased pain.The following devices were replaced during revision: · liner f.Met.Back glen.Standard (product code: 1377.50.010, lot.22at1ym - ster.(b)(4)) - sold in us.· smr humeral head ø48 mm (product code: 1322.09.480 , lot.2120289 - ster.(b)(4)) - sold in us.· smr uncement.Glenoid # std (product code: 1375.20.010, lot.2309307 - ster.(b)(4)) - not sold in us.· bone screw ø6,5 h.35mm (product code: 8420.15.040, lot: 2322192 - ster.(b)(4)) - sold in us.· bone screw ø6,5 h.35mm (product code: 8420.15.040, lot: 2322192 - ster.(b)(4)) - sold in us.Patient: male, 66 years old, approximate height (m): 1.86, approximate weight (kg): 87.Event occurred in germany.
Additional Manufacturer Narrative
Checking the dhrs of the lot number involved no pre-existing anomalies were highlighted on the pieces manufactured with lot number 22at1ym.According to our data at least (b)(4) pieces out of (b)(4) manufactured with lot.22at1ym - ster.(b)(4) have been implanted, and this is the first and only complaint received.The explant was received at limacoporate for further analysis and from a visual inspection it was noticed that the metal-back shows localized wear and damage on one side.Additionally, the presence of small burrs was observed on the surface, which are presumed to be caused by surgical instrumentation used during explantation.The x-ray of post-op ((b)(6) 2023), x- rays of revision surgery and operative notes were provided by the complaint source.The available information and x-rays were evaluated by a medical consultant.Following, the medical consultant comments: "postop radiographs look fine, perfect restroration of cor.The or report is unremarkable.The most likely mode of failure is rotator cuff failure here.There is no sign of implant related failure." in conclusion, considering that the check of dhrs revealed no pre-existing anomalies in the involved lot number and according to the medical consultant the most likely cause of failure is patient's related (rotator cuff failure), we may classify this event as not product related.Pms data: according to limacorporate pms data, the revision rate of l1 liners - belonging to the family codes (b)(6) - due to wear 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 will continue monitoring the market to promptly detect any further similar issue.This is a final mdr report.

• Brand Name: SMR SYSTEM
• Common Device Name: SMR SYSTEM - METAL BACK LINER STANDARD
• 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; udine, 33038
• MDR Report Key: 20639159
• Report Number: 3008021110-2024-00098
• Device Sequence Number: 7506936
• Product Code: KWS
• UDI-Device Identifier: 08033390272681
• UDI-Public: 08033390272681
• Combination Product (Y/N): N
• PMA/510(K) Number: K113254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 07/07/2025

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: 1377.50.010
• Device Catalogue Number: 1377.50.010
• Device Lot Number: 22AT1YM
• 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: 07/07/2025
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 87 KG