MAUDE Adverse Event Report: GLOBAL MANUFACTURING TECHNOLOGY PTY LTD PARAGON HIP SYSTEM; PROSTHESIS, HIP, SEMI-CONSTRAINED

Catalog Number GM08001-202-03

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hip Fracture (2349)

Event Date 06/14/2020

Event Type  Injury  

Manufacturer Narrative

The explanted devices were not returned to the manufacturer for further investigation.Manufacturing records were reviewed and determined that all products associated with this event were manufactured, sterilised and packaged to the correct specifications at the time of manufacture.No deviation from the process or non conformity of product was observed on the manufacturing and sterilisation records of the products involved that would have caused the reported adverse event.There was no evidence to suggest that the product malfunction has caused the bone fracture experienced by the patient.

Event Description

Patient was revised due to periprosthetic fracture on (b)(6) 2020.

• Brand Name: PARAGON HIP SYSTEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED
• Manufacturer (Section D): GLOBAL MANUFACTURING TECHNOLOGY PTY LTD; unit 10, 7 meridian place; baulkham hills, new south wales 2153 ; AS 2153
• Manufacturer (Section G): UNIT 10, 7 MERIDIAN PLACE; unit 10, 7 meridian place; baulkham hills, new south wales 2153 ; AS 2153
• Manufacturer Contact: robert clemente ; unit 10, 7 meridian place; baulkhma hills, new south wales 2153 ; AS 2153
• MDR Report Key: 10280984
• MDR Text Key: 199048381
• Report Number: 3004537778-2020-00005
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2023
• Device Catalogue Number: GM08001-202-03
• Device Lot Number: 188PS-66
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2018
• 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
• Patient Age: 79 YR