MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR FINNED HUMERAL BODY

Model Number 1350.15.110

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 11/29/2022

Event Type  malfunction  

Manufacturer Narrative

By the check of the device history records, no pre-existing anomaly was detected on the (b)(4) humeral bodies released with lot 1802875 ster.1800105.This is the first and only complaint received on this lot number (182875).We will submit a final report after the final investigation.

Event Description

Intra-operative issue occurred on (b)(6) 2022: during shoulder surgery, the humeral inserter (code and lot not known) did not fit on the humeral body with code 1350.15.110, lot 1802875, ster.1800105.This event occurred in spain.

• Brand Name: SMR FINNED HUMERAL BODY
• Type of Device: SMR FINNED HUMERAL BODY
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via naizonale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via naizonale 52; villanova di san daniele, udine 33038
• MDR Report Key: 16596539
• MDR Text Key: 311981989
• Report Number: 3008021110-2023-00024
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K101263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 1350.15.110
• Device Lot Number: 1802875
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization