MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; REVERSE LINER 40MM STANDARD

Model Number	1365.50.810
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed on (b)(6) 2026 due to cuff failure.Previous surgery is unknown, as well as complete product information of original implant.The patient had a pre-existing reverse configuration of smr shoulder prosthesis consisting of a tt metal back baseplate 360 + 4mm (pn 1375.15.524) with an 40mm glenosphere (pn 1374.09.121).After suffering from acromion to acromion fracture, due to over lateralization according to the surgeon who revised the implant, the patient became lax.During the revision procedure, the surgeon chose to increase the poly liner thickness from a standard size to a +6mm: smr reverse liner standard 40mm (pn 1365.50.810) was removed and replaced with thicker one.This change guaranteed the appropriate tensioning to the rotator cuff.The surgeon decided to not replace other components such as the humeral reverse body because of the risk of a tuberosity fracture.Surgery was completed as intended.The patient is male, date of birth (b)(6) 1959.The event occurred in the united states.
Additional Manufacturer Narrative
Explanted component was discarded therefore not available for identification and analysis.Review of manufacturing records cannot be performed since lot number is unknown.The manufacturer will submit a final report as soon as the investigation is completed.

• Brand Name: SMR SHOULDER
• Common Device Name: REVERSE LINER 40MM STANDARD
• 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: 24813212
• Report Number: 3008021110-2026-00168
• Device Sequence Number: 14959331
• Product Code: PHX
• UDI-Device Identifier: 08033390102919
• UDI-Public: 8033390102919
• Combination Product (Y/N): N
• PMA/510(K) Number: K142139
• 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): 04/08/2026

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: 1365.50.810
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2026
• 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: 67 YR
• Patient Sex: Male