MAUDE Adverse Event Report: GLOBAL MANUFACTURING TECHNOLOGY PTY LTD PARAGON HIP STEM; PARAGON STEM HIGH OFFSET SIZE 7, PRODUCT CODE: LZO

Catalog Number GM08001-202-07

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

Patient Problem Abscess (1690)

Event Date 05/27/2021

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 infection.

Event Description

The patient was revised for infection on (b)(6) 2021.This is the third revision due to infection for this patient.All implants were removed and replaced in this revision.

• Brand Name: PARAGON HIP STEM
• Type of Device: PARAGON STEM HIGH OFFSET SIZE 7, PRODUCT CODE: LZO
• Manufacturer (Section D): GLOBAL MANUFACTURING TECHNOLOGY PTY LTD; 17 bridge street; pymble, new south wales 2073 ; AS 2073
• Manufacturer (Section G): GLOBAL MANUFACTURING TECHNOLOGY PTY LTD; 17 bridge street; pymble, new south wales 2073 ; AS 2073
• Manufacturer Contact: robert clemente ; 17 bridge street; pymble, new south wales 2073 ; AS 2073
• MDR Report Key: 11973445
• MDR Text Key: 255345319
• Report Number: 3004537778-2021-00002
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 06/10/2021

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 Operator: Health Professional
• Device Catalogue Number: GM08001-202-07
• Device Lot Number: 198PS69
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/27/2021
• Initial Date FDA Received: 06/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2019
• 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: 53 YR