MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER SYSTEM; CONNECTOR LAT +4 MM + SCREW - SMALL-R

Model Number	1374.15.314
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Checking the manufacturing charts, no pre-existing anomaly was discovered in the items belonging to the same product codes and lot numbers as those of the components involved in this event.The manufacturer will submit a final mdr as soon as the investigation is complete.
Event or Problem Description
On (b)(6) 2019, patient had left reverse total shoulder.On (b)(6) 2020, patient dislocated shoulder for the first time.When visiting the local urgent care, the shoulder could not be reduced.Patient fell asleep and somehow his shoulder reduced.X-ray reveals a well reduced reverse tsa, no fx's.The doctor notes: "if he dislocates again, we will have to consider a constrained liner with or without an extension." on (b)(6) 2020, visit the doctor notes "he appears to have torn his subscapularis", which he states, "there is no reason to go back and do anything".During on (b)(6) 2022 visit, the doctor noted the following: "he has had 2 additional episodes of subluxation/dislocation.The most recent was on (b)(6) 2021, which he was able to reduce on his own." treatment options were discussed, and the doctor requested a custom-made device 44mm all poly glenosphere.Doctor also mentions "possibility of an infection".Cultures were sent but the manufactured did not receive the outcome.The components involved in this event are the following: smr small-r connector +4 (part code: 1374.15.314, lot number: 1915239, sterilization: 1900342) smr metal-back glenoid small r (part code: 1375.21.005, lot number: 1915286, sterilization: 1900396).The date of the revision surgery is currently unknown.The patient is a male, date of birth on (b)(6) 1955.The event happened in the united states.

• Brand Name: SMR SHOULDER SYSTEM
• Common Device Name: CONNECTOR LAT +4 MM + SCREW - SMALL-R
• 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: 24207499
• Report Number: 3008021110-2026-00116
• Device Sequence Number: 14810376
• Product Code: KWS
• UDI-Device Identifier: 08033390152112
• UDI-Public: 08033390152112
• Combination Product (Y/N): N
• PMA/510(K) Number: K183042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 01/29/2026

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: 1374.15.314
• Device Lot Number: 1915239
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2026
• 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: Other
• Patient Sex: Unknown