MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; HYBRID GLENOID SMALL LOW - PEG S

Model Number	1379.59.100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	05/18/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Involved device has been discarded, therefore is not available for identification and analysis.No review of manufacturing records can be performed since lot number is unknown.
Event or Problem Description
Revision surgery was performed on (b)(6) 2026 due to cuff failure.The patient underwent a primary total shoulder arthroplasty about 6 year ago with a catalyst humeral head and lima tt hybrid glenoid (pn 1379.59.100).Due to cuff failure, the patient has been converted to a reverse configuration, removing the pre-existing glenoid and replacing it with the tt hybrid reverse baseplate (pm 1379.15.160) and 36mm glenosphere (pn 1374.09.111).No information regarding humeral part were provided.Patient is female, date of birth (b)(6) 2026.The event occurred in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: HYBRID GLENOID SMALL LOW - PEG S
• 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: 25680178
• Report Number: 3008021110-2026-00252
• Device Sequence Number: 4707648
• Product Code: MBF
• UDI-Device Identifier: 08033390121002
• UDI-Public: 8033390121002
• Combination Product (Y/N): N
• PMA/510(K) Number: K163397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 07/01/2026

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: 1379.59.100
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2026
• 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: 69 YR
• Patient Sex: Female