MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CEMENTLESS FINNED STEM; FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.14MM

Model Number 1304.15.140

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Arthralgia (2355)

Event Date 03/15/2022

Event Type  Injury  

Event Description

We became aware of a shoulder revision surgery of a smr reverse prosthesis performed on (b)(6) 2022, due to infection.All the implants got removed: smr cementless finned stem (product code 1304.15.140, lot #2110020 - ster.2100209).Smr reverse humeral body short (product code 1352.15.005, lot #2115113 - ster.2100246).Smr reverse hp liner short (product code 1365.09.010, lot #2105477 - ster.2100158) - product not sold in the us.Smr reverse hp glenosphere 40 mm (product code 1374.50.400, lot #2109955 - ster.2100198) - product not sold in the us.Cmd 21-1225 glenoid implant (product code 9618.16.002, lot #2118264 - ster.2100274) - customized implant.Cortical bone screw d.4,5 l.26mm (product code 8431.15.026, lot #2015480 - ster.2000318).Cortical bone screw d.4,5 l.30mm (product code 8431.15.030, lot #2007936 - ster.2000214).Cortical bone screw d.4,5 l.32mm (product code 8431.15.032, lot #2016860 - ster.2000338).A hemi prosthesis with cta head was implanted.The surgeon requested a customized implant for the glenoid.It was reported that the pathogen responsible for the infection is not known.Previous surgery took place on (b)(6) 2021.Patient is a female, 80 years old.Event happened in new zealand.

Manufacturer Narrative

Checking the sterilization charts of the involved lot #s, no pre-existing anomaly was found on the devices.Therefore, the products with these lot #s have been properly sterilized before being placed on the market.The items involved were not available to be returned to limacorporate for further analysis.No additional details were available on this post-operative issue, specifically the pathogen responsible for the infection and any pre-operative or post-operative x-rays related to the revision surgery.Based on the very few information received, we are not able to further investigate the root cause of the event.However, considering that the check of the sterilization charts highlighted no anomalies on the components manufactured with the involved lot #s, we can state that the event was not product related.Pms data: according to limacorporate pms data, revision rate of smr reverse implants due to infection is (b)(4).Based on the root cause analysis performed and according to the relevant pms data, no corrective actions required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.Note: this is a combined initial-final mdr.

• Brand Name: SMR CEMENTLESS FINNED STEM
• Type of Device: FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.14MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 15860253
• MDR Text Key: 304283534
• Report Number: 3008021110-2022-00123
• 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: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1304.15.140
• Device Lot Number: 2110020
• 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): Other