MAUDE Adverse Event Report: Limacorporate S.p.A. SMR System; SMR System - Humeral Body Reverse Short

Model Number	1352.15.005
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abnormal Vaginal Discharge (2123); Joint Dislocation (2374)
Date of Event	07/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The complaint source reported that a first-stage shoulder revision surgery was performed on (b)(6) 2026 due to a dislocation.During the procedure, the glenosphere, custom screw, liner, short reverse body, and associated screw were explanted.A new screw from a standard reverse body was inserted into the stem, which was left in situ.According to the surgeon, a possible contributing factor was an infection.The surgeon also noted that the reverse body screw was not fully engaged and that insufficient bone was removed from the area at reverse body / stem connection.A new custom screw has been requested to limacorporate for the planned second-stage revision surgery.Hereby the list of devices that were implanted in the previous surgery: smr reverse humeral body short (product code: 1352.15.005, lot: 2602989 - ster: 260004) - sold in us smr reverse liner standard (product code: 1360.50.010, lot: 24at2c8 - ster: 2400162) - not sold in us smr eccent.Glenosphere ø 36mm (product code: 1376.15.031, lot: 2601926 - ster:2600023) - not sold in us cortic.Bone screw d.5 l.32 mm (product code: 8432.15.032, lot: 2521662 - ster: 2500150) - sold in us cortic.Bone screw d.5 l.34 mm (product code: 8432.15.034, lot: 2528462 - ster: 2500190) - sold in us cortic.Bone screw d.5 l.36 mm (product code: 8432.15.036, lot: 2517337 - ster: 2500120) - sold in us cortic.Bone screw d.5 l.48 mm (product code: 8432.15.048, lot: 2305906 - ster: 2300058) - sold in us cmd* 25-1748 glenoid implant (product code: 9617.Pe0.A0, lot: 2610182 - ster: 2600074) - not sold in us cmd* 25-1748 glenoid psi set 3 (product code: 9701.66.Azj, lot: 2610183 - ster: 2600060) - not sold in us cmd* 25-1748 glenoid anatomy (product code: 9705.An.2ey, lot: 2610184 - ster: 2600060) - not sold in us (*cmd: custom made device) event occurre in united kingdom.
Additional Manufacturer Narrative
The review of device history records did not highlight any pre-existing anomalies on all the lot numbers involved.A final report will be submitted after the investigation is completed.

• Brand Name: SMR System
• Common Device Name: SMR System - Humeral Body Reverse Short
• Manufacturer (Section D): Limacorporate S.p.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 50069636
• Report Number: 3008021110-2026-00297
• Device Sequence Number: 10288039
• Product Code: KWS
• UDI-Device Identifier: 08033390272551
• UDI-Public: 08033390272551
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other
• Type of Report: Initial
• Report Date (Section B): 07/29/2026

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: 1352.15.005
• Device Lot Number: 2602989
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 07/29/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown