MAUDE Adverse Event Report: LIMACORPORATE S.P.A. BONE SCREWS; BONE SCREWS DIA. 6.5 X H. 50 MM

Model Number 8420.15.070

Device Problems Material Integrity Problem (2978); Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 02/28/2024

Event Type  Injury  

Manufacturer Narrative

No pre-existing anomaly was detected by the check of manufacturing charts of lot numbers involved.This is the first complaint received on the lot numbers involved.We will submit a final report after the final investigation.

Event Description

Hip revision surgery performed on (b)(6) 2024, due to breakage of bone screws and hemispheric module, with loosening of acetabular cup.The following devices were explanted: · tt hemispheric module ø50 mm (product code: 5533.14.500, lot.1600986 - ster.2100173) - not sold in us · delta-one-tt acetab.Cup ø50mm (product code: 5549.14.501, lot.2114220 - ster.2100253) - not sold in us · bone screw ø6,5 h.50mm (8420.15.070, lot.2105840 - ster.2100141) · bone screw ø6,5 h.50mm (8420.15.070, lot.2114898 - ster.2100236) previous surgery performed on (b)(6) 2021.Patient age: 26 years old event occurred in italy.

• Brand Name: BONE SCREWS
• Type of Device: BONE SCREWS DIA. 6.5 X H. 50 MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova, san daniele del friuli 33038
• MDR Report Key: 18958955
• MDR Text Key: 338353351
• Report Number: 3008021110-2024-00025
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K172456
• 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: 03/21/2024

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: 8420.15.070
• Device Lot Number: 2105840
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 03/22/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention