MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER SYSTEM; REVERSE LINERS 36MM (UHMWPE) RETENTIVE +6MM

Model Number	1361.50.820
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed on (b)(6) 2026 due to shoulder dislocation.Previous surgery occurred on (b)(6) 2026 when patient underwent reverse total shoulder arthroplasty with smr humeral components consisting of: - revision stem dia16mm h 150mm (pn 1308.15.164, lot 2510198, sterilization (b)(6).- smr 140° humeral body reverse (pn 1352.15.011, lot 2520339, sterilization (b)(6).- extension for humeral reverse body (pn 1352.15.001, lot 2516851, sterilization (b)(6) - retentive liner +6mm 36mm (pn 1361.50.820, lot 14at4db, sterilization (b)(6).No information regarding original glenoid components was provided.During revision all the above mentioned components were removed and replaced with similar items, with exception of a 140° finer humeral body reverse (pn 1352.15.051) and a retentive liner +6mm dia40mm (pn 1365.50.821) for size compatibility with the djo 40mm lateralized glenosphere that has been implanted.Surgery was completed as intended.Patient is female, date of birth (b)(6) 1940.The event occurred in the united states.
Additional Manufacturer Narrative
Review of manufacturing records for involved batch did not highlight any pre-existing anomaly or non-conformity that could have contributed to reported issue.The manufacturer will submit a final report as soon as the investigation is completed.

• Brand Name: SMR SHOULDER SYSTEM
• Common Device Name: REVERSE LINERS 36MM (UHMWPE) RETENTIVE +6MM
• 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: 24950298
• Report Number: 3008021110-2026-00184
• Device Sequence Number: 17462415
• Product Code: PHX
• UDI-Device Identifier: 08033390273640
• UDI-Public: 8033390273640
• Combination Product (Y/N): N
• PMA/510(K) Number: K110598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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,Followup
• Report Date (Section B): 07/03/2026

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: 1361.50.820
• Device Lot Number: 24AT4DB
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 07/03/2026
• 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: 85 YR
• Patient Sex: Female