MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER SYSTEM; TT HYBRID GLENOID BASEPLATE 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	01/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explanted component has been discarded therefore cannot be returned to manufacturer for identification and analysis.No review of manufacturing records for complained part can be performed either since product information 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 cuff failure.Previous surgery was performed on (b)(6) 2020.During the revision surgery the pre-existing tt hybrid cem.Glenoid small (pn 1379.59.110) has been removed and prosthesis converted to reverse configuration implanting a new smr tt hybrid reverse baseplate (pn 1379.15.160) and smr glenosphere dia.36mm (pn 1374.09.111).No information regarding original and revised humeral components were provided.Surgery was completed as intended.Patient is female, date of birth (b)(6) 1954.Event occurred in the united states.

• Brand Name: SMR SHOULDER SYSTEM
• Common Device Name: TT HYBRID GLENOID BASEPLATE 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: 24680602
• Report Number: 3008021110-2026-00156
• Device Sequence Number: 9726775
• Product Code: PHX
• UDI-Device Identifier: 08033390121552
• UDI-Public: 8033390121552
• 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): 03/23/2026

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: 03/24/2026
• 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: 71 YR
• Patient Sex: Female