MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER; LINER

Model Number	1377.50.005
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	05/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No pre-existing anomalies detected by the check of the device history records of the lot number involved.This is the first and only complaint recorded on this lot number: (17at1fu).A final report will be submitted after the investigation.
Event or Problem Description
Shoulder revision surgery due to breakage of the liner (product code 1377.50.005, lot: 17at1fu).The components lost their articulation, causing metallosis.Revision surgery performed on (b)(6) 2026.Previous surgery date in not known.This event occurred in italy.

• Brand Name: SMR SHOULDER
• Common Device Name: LINER
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale, 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 25275484
• Report Number: 3008021110-2026-00243
• Device Sequence Number: 15892425
• Product Code: KWS
• UDI-Device Identifier: 08033390002592
• UDI-Public: 08033390002592
• Combination Product (Y/N): N
• PMA/510(K) Number: K113254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/25/2026

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: 1377.50.005
• Device Lot Number: 17AT1FU
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown