MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR HUMERAL HEAD Ø42 MM; HUMERAL HEADS (COCRMO) DIA.42MM

Model Number 1322.09.420

Device Problem Patient Device Interaction Problem (4001)

Event Date 10/03/2023

Event Type  Injury  

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 no pre-operative or post-operative x-rays related to the revision surgery were accessible.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 anatomic implants (total + hemi) 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 continues monitoring the market to promptly detect any similar issue.Note: this is a combined initial-final mdr.

Event Description

Shoulder revision surgery of a smr anatomic total performed on (b)(6), 2023, due to infection.The following components got explanted: smr humeral head ø42 mm (product code 1322.09.420, lot #0604645 - ster.1200203) neutral adaptor taper standard (product code 1330.15.270, lot #1406455 - ster.1400228) smr finned humeral body (product code 1350.15.110, lot #1502261 - ster.1500061) smr uncemented glenoid #small-r (product code 1375.20.005, lot #1502067 - ster.1500089) - product not sold in the us smr metalback liner 6mm small-r (product code 1377.50.006, lot #1308323 - ster.1300245) bone screw ø6,5 h.20mm (product code 8420.15.010, lot #1501924 - ster.1500095) bone screw ø6,5 h.25mm (product code 8420.15.020, lot #1502403 - ster.1500115) new short reverse body, adaptor taper and cta head were implanted.No device was placed in the glenoid.It was reported that the surgical plan is to request a customized glenoid implant, so the glenoid was plugged with the cement.Samples were taken during the surgery.Previous surgery took place on (b)(6), 2015.Patient is a female, 70 years old.Event happened in (b)(6).

• Brand Name: SMR HUMERAL HEAD Ø42 MM
• Type of Device: HUMERAL HEADS (COCRMO) DIA.42MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 17911344
• MDR Text Key: 325347177
• Report Number: 3008021110-2023-00113
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K100858
• 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: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1322.09.420
• Device Lot Number: 0604645
• 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