MAUDE Adverse Event Report: LIMACORPORATE S.P.A. CORTICAL BONE SCREW D.4,5 L.20MM; CORTICAL SCREW DIA. 4,5MM L 20MM

Model Number 8431.15.020

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Implant Pain (4561)

Event Date 04/08/2024

Event Type  Injury  

Manufacturer Narrative

Checking the manufacturing charts of involved lots#: 2204927, #2106512 and #: 2108017, no pre-existing anomalies were found on the 70, 120 and 120 components manufactured with those lot#s respectively.This is the first and only complaint received on those lot#s.We submit a final mdr as soon as the investigation is complete.

Event Description

Shoulder revision surgery of a smr reverse prosthesis performed on (b)(6) 2024, due to pain.It was stated that the patient started experiencing pain, and the surgeon hypothesized that the superior bone screw on the glenoid was the cause for the pain.No traumatic event was reported.After removing the superior bone screw, the whole metalback implant was found to be loose.All the glenoid components were removed: smr uncemented glenoid #small-r (product code: 1375.20.005, lot#: 2204927 - ster.2200101) product not sold in the us.Cortical bone screw d.4,5 l.20mm (product code: 8431.15.020, lot#: 2106512 - ster.2100140).Cortical bone screw d.5 l.36 mm (product code: 8432.15.036, lot#: 2108017 - ster.2100140).Smr reverse hp glenosphere 40 mm (product code: 1374.50.400, lot#: 2204755 - ster.2200065) product not sold in the us.Smr small-r connector +2 (product code: 1374.15.312, lot#: 2208272 - ster.2200107).Smr reverse hp liner short (product code: 1365.09.010, lot#: 2125746 - ster.2200042) product not sold in the us.The site was debrided and thoroughly washed out, and an adaptor and humeral head temporarily implanted.Infection might be present.Previous surgery on (b)(6) 2022.Patient is a female, 76 years old.Event happened in (b)(6).

• Brand Name: CORTICAL BONE SCREW D.4,5 L.20MM
• Type of Device: CORTICAL SCREW DIA. 4,5MM L 20MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 19170881
• MDR Text Key: 340900268
• Report Number: 3008021110-2024-00038
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• PMA/PMN Number: K200171
• 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: 04/23/2024

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: 8431.15.020
• Device Lot Number: 2106512
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2024
• 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