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

Model Number	1377.50.010
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation a review of the device history records (dhr) of liner f.Met.Back glen.Standard could not be performed, as the lot number of the device is unknown.Consequently, traceability to manufacturing and quality records was not possible.A final mdr report will be shared once the investigation is complete.
Event or Problem Description
A shoulder revision surgery was performed on (b)(6) 2023 due to wear of the liner f.Met.Back glen.Standard (product code: 1377.50.010, lot number: unknown).As a result, the surgeon converted the implant to a reverse configuration and explanted the following components: - finned stem dia.22 mm, l.80 (product code: 1304.15.220, lot number: unknown).- humeral head dia.54 mm (product code: 1322.09.540, lot number: unknown).- adaptor taper neutral (product code: 1330.15.270, lot number: 0804233, sterilization no.: 0800231).- humeral body finned (product code: 1350.15.110, lot number: unknown).- liner f.Met.Back glen.Standard (product code: 1377.50.010, lot number: unknown).- metal-back glenoid standard (product code: 1375.20.010, lot number: unknown).The initial shoulder implantation surgery was performed on (b)(6) 2008.Event happened in australia.

• Brand Name: SMR SYSTEM
• Common Device Name: METAL BACK LINER STANDARD
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 24223083
• Report Number: 3008021110-2026-00117
• Device Sequence Number: 8579413
• Product Code: KWS
• UDI-Device Identifier: 08033390272681
• UDI-Public: 08033390272681
• Combination Product (Y/N): Y
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/30/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown