• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

GLOBAL MANUFACTURING TECHNOLOGY PTY LTD PARAGON HIP SYSTEM PROSTHESIS, HIP, SEMI-CONSTRAINED Back to Search Results
Catalog Number GM08001-203-02
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/19/2020
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, sterilized 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 sterilization 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 leg length discrepancy experienced by the patient.

 
Event Description

Patient was revised for leg length discrepancy on (b)(6) 2020. The size 2 paragon stem position was higher than where the broach sat. As a result the patient's leg was longer than desired. The patient was not comfortable with the change on leg length so the patient was revised to a size 1 stem.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePARAGON HIP SYSTEM
Type of DevicePROSTHESIS, 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)
GLOBAL MANUFACTURING TECHNOLOGY PTY LTD.
unit 10, 7 meridian place
baulkham hills, new south wales 2153
AS  2153
Manufacturer Contact
robert clemente
unit 10, 7 meridian place
baulkham hills, new south wales  2153
  2153
MDR Report Key10198441
Report Number3004537778-2020-00004
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 06/26/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/26/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberGM08001-203-02
Device LOT Number178PS-162
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/23/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/26/2020 Patient Sequence Number: 1
-
-