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

Model Number	1379.59.110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	02/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device has not been returned for identification and analysis.No review of manufacturing records can be performed since lot number is unknown.The manufacturer will submit a final report as soon as the investigation is completed.
Event or Problem Description
Revision surgery was performed on (b)(6) 2026 due to rotator cuff failure.Previous surgery is unknown, as well as complete product information of original shoulder prosthesis.During revision the surgeon removed the pre-existing tt hybrid cem.Glenoid small (pn: 1379.59.110) as well as all other components and converted the prosthesis to a reverse configuration implanting the following: finned stem short dia17mm (pn: 1304.15.017), humeral body reverse (pn: 1352.15.010), extension for humeral reverse body (pn: 1352.15.001), reverse liner standard (pn: 1360.50.810), tt hybrid reverse baseplate small (pn: 1379.15.160), glenosphere dia 36mm (pn: 1374.09.111).Surgery was completed as intended.Patient is male, date of birth on (b)(6) 1962.The event occurred in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: HYBRID GLENOID SMALL - 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: 24950299
• Report Number: 3008021110-2026-00182
• Device Sequence Number: 5278312
• Product Code: KWS
• UDI-Device Identifier: 08033390266703
• UDI-Public: 8033390266703
• Combination Product (Y/N): N
• PMA/510(K) Number: K163397
• 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): 04/21/2026

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: 1379.59.110
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2026
• 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: 63 YR
• Patient Sex: Male