MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER; HUMERAL HEAD (COCRMO) - DIA.44MM H.14

Model Number	1321.09.441
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Checking the manufacturing charts of the involved lots: #2126295, no pre-existing anomaly was found on the 6 devices manufactured respectively.This is the first and only complaint received on those lot#s.We submit a final mdr when the investigation is complete.
Event or Problem Description
Shoulder revision surgery of a smr anatomic total prosthesis performed on (b)(6) 2025, due to cuff failure.According to the information received, after a deterioration of rotator cuff, it was advised that patient convert to a reverse construct.The following devices were explanted: smr humeral head d.44 h.14mm (product code: 1321.09.441, lot#: 2126295 - ster.2200024).Neutral adaptor taper standard (product code: 1330.15.270, lot#: 2014099 - ster.Unknown).Smr trauma humerak body# long (product code: 1350.15.020, lot#: 1909580 - ster.1900265).Tt hybrid cemented glenoid small (product code: 1379.59.110, lot#: 2321146 - ster.2300202).A 140° reverse body was implanted with a +3 liner.The revision baseplate was implanted with a 36mm glenosphere.Primary surgery took place on (b)(6) 2023.Patient is a female, 67 years old.Event happened in the us.

• Brand Name: SMR SHOULDER
• Common Device Name: HUMERAL HEAD (COCRMO) - DIA.44MM H.14
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 22104992
• Report Number: 3008021110-2025-00050
• Device Sequence Number: 18196814
• Product Code: HSD
• UDI-Device Identifier: 08033390116268
• UDI-Public: 08033390116268
• Combination Product (Y/N): N
• PMA/510(K) Number: K161476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• 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): 05/29/2025

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: 1321.09.441
• Device Catalogue Number: 1321.09.441
• Device Lot Number: 2126295
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/29/2025
• 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 Sex: Unknown