MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CEMENTLESS FINNED STEM; SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.18MM

Model Number 1304.15.180

Device Problem Patient Device Interaction Problem (4001)

Event Date 11/03/2021

Event Type  Injury  

Event Description

Shoulder revision surgery of smr reverse performed on (b)(6) 2021, due to infection.The patient came with pain and an infection was found.During the revision surgery the following components were explanted: - smr cementless finned stem (product code: 1304.15.180, lot number: 1506296, sterilization number not available).- smr reverse finned humer.Body (product code: 1352.15.050, lot number: 1400097, sterilization number 1400077).- smr glenosphere ø36mm small-r (product code: 1376.09.025, lot number: 1400770, sterilization number 1400041).The revision surgery was completed with antibiotic and cement spacer was implanted.Patient was a male, 84 years old.Previous surgery took place in 2014.Event occurred in us.

Manufacturer Narrative

The sterilization charts were checked with the following results: - no pre-existing anomaly was found on the 39 smr glenosphere ø36mm small-r, that belong to product code: 1376.09.025, lot number: 1400770 and the sterilization number: 1400041.- no pre-existing anomaly was found on the 63 smr reverse finned humer.Body, that belong to product code: 1352.15.050, lot number: 1400097, sterilization number: 1400077.- no pre-existing anomaly was found on the 36 smr cementless finned stem, that belong to product code :1304.15.180, lot number: 1506296, sterilization number not available therefore, we can state that the involved components were regularly sterilized before being placed on the market.Explants analysis and further information: the items involved were returned to lima corporate for further analysis.From the explants, the product code and the lot number of the liner explanted were retrieved: smr reverse liner product code: 1360.50.820, lot number: 14l0711.The dhr of this product was checked, finding no anomaly.Further information was requested to the complaint source, in particular: - specimen taken during the surgery and the pathogen responsible for the infection.- patient's clinical information.- x-rays.- pictures of the explants.- date of previous surgery.- if the cement spacer was revised.The complaint source sent the pictures of the explants, no more information is available.Based on the few information received, in conclusion: - the check of the dhr highlights no pre-existing anomalies on the components involved.- according to the complaint source, there is no more information available on this issue, apart from the pictures of the explants.- further analysis on the explants is not deemed necessary.We are not able to establish the root cause of the infection reported.However, we can suppose that the event was not product related.(b)(4).No specific corrective action is needed for this case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.This is a final report.According to the fda communication received on october 13th 2022 by email, this report was delayed due to the enrollment process.

• Brand Name: SMR CEMENTLESS FINNED STEM
• Type of Device: SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.18MM
• 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: 15697051
• MDR Text Key: 302687289
• Report Number: 3008021110-2022-00092
• 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: 10/28/2022

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: 1304.15.180
• Device Lot Number: 1506296
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention