MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER; HUMERAL HEAD

Model Number	1322.09.520
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	02/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
By checking the manufacturing charts of the involved lot number 1309283, no pre-existing anomaly was found on a total of (b)(4) items manufactured with the same lot number 1309283 and sterilization (b)(4).We will submit the final mdr as soon as the investigation is complete.
Event or Problem Description
Shoulder revision due to cuff failure performed on (b)(6) 2025.The patient had subscapularis tear, and the anatomic total shoulder was revised to reverse total shoulder.The following components were removed and replaced with reverse components: smr humeral head ø52 mm (part code 1322.09.520, lot number 1309283, sterilization (b)(4)).Smr ecc.Adaptor taper standard (part code 1330.15.274, lot number 141061, sterilization (b)(4)).Smr finned humeral body (part code 1350.15.110, lot number 1409544, sterilization (b)(4)).Liner f.Met.Back glen.Small (part code 1377.50.020, lot number 1407195, sterilization (b)(4)).Previous surgery took place on (b)(6) 2015.The patient is a male, date of birth (b)(6) 1945.Event happened in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: HUMERAL HEAD
• 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: 21663546
• Report Number: 3008021110-2025-00035
• Device Sequence Number: 20748825
• Product Code: HSD
• UDI-Device Identifier: 08033390001427
• UDI-Public: 08033390001427
• Combination Product (Y/N): N
• PMA/510(K) Number: K100858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 03/21/2025

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: 1322.09.520
• Device Lot Number: 1309283
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2025
• 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