MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CEMENTLESS FINNED STEM; FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.16MM - SMR SHOULDER SYSTEM

Model Number 1304.15.160

Device Problem Patient Device Interaction Problem (4001)

Event Date 07/14/2016

Event Type  Injury  

Manufacturer Narrative

No pre-existing anomaly was found by checking the manufacturing and sterilization charts of the lot numbers involved.We will submit a final report after the conclusion of the investigation.

Event Description

Shoulder revision surgery due to infection performed on (b)(6) 2016.The previous surgery took place on (b)(6) 2016.A previous infection before (b)(6) 2016 was occurred.During the revision surgery, the following components were explanted and a spacer was implanted: - smr cementless finned stem (product code 1304.15.160, lot number 1520346, sterilization number (b)(4)); - smr reverse humeral body (product code 1352.20.010, lot number 1600871, sterilization number (b)(4)); - smr reverse hp liner medium (product code 1365.09.015, lot number 1520285, sterilization number (b)(4)); - smr connector small r (product code 1374.15.305, lot number 1605780, sterilization number (b)(4)); - smr reverse hp glenosph.40 mm (product code 1374.50.400, lot number 1606432, sterilization number (b)(4)); - smr uncement.Glenoid #small-r (product code 1375.20.005, lot number 1603031, sterilization number (b)(4)); - bone screw ø6,5 h.30mm (product code 8420.15.030, lot number 1603541, sterilization number (b)(4)).This surgery was the first stage of revision (the second stage took place on (b)(6) 2017).The patient is a female, 86 years old, height 157 cm, weight 67,50 kg.Event occurred in united kingdom.

• Brand Name: SMR CEMENTLESS FINNED STEM
• Type of Device: FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.16MM - SMR SHOULDER SYSTEM
• 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: 16769628
• MDR Text Key: 313601224
• Report Number: 3008021110-2023-00041
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1304.15.160
• Device Lot Number: 1520346
• 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