MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; LINER FOR METAL-BACK (UHMWPE) LINER SMALL

Model Number	1377.50.020
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Metal Related Pathology (4530); Loose body in joint (4926)
Date of Event	03/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed on (b)(6) 2026 due to disassembly of components and metallosis.Previous surgery is unknown, as well as complete product information of original implant.During revision, the pre-existing liner for metal back glenoid small (pn 1377.50.020) was found loose from the smr metal-back glenoid small (pn 1375.21.020) and floating in the joint, causing metal on metal friction and therefore severe metallosis.Surgeon removed all the glenoid components, as well as the pre-existing smr humeral head ø50 mm (pn 1322.09.500) and adaptor taper (pn 1330.15.274) and re-implanted a new taper and head on the humeral side to restore shoulder functionality with a hemi arthroplasty.Surgery was completed as intended.Patient is male, date of birth (b)(6)1960.The event occurred in the united states.
Additional Manufacturer Narrative
Explanted components have been discarded therefore cannot be returned to manufacturer for identification and analysis.No review of manufacturing records for complained parts can be performed either since product information is unknown.The manufacturer will submit a final report as soon as the investigation is completed.

• Brand Name: SMR SHOULDER
• Common Device Name: LINER FOR METAL-BACK (UHMWPE) LINER SMALL
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 25067102
• Report Number: 3008021110-2026-00198
• Device Sequence Number: 13351714
• Product Code: KWS
• UDI-Device Identifier: 08033390272704
• UDI-Public: 8033390272704
• Combination Product (Y/N): N
• PMA/510(K) Number: K113254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• 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): 05/04/2026

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: 1377.50.020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2026
• 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 Age: 65 YR
• Patient Sex: Male