MAUDE Adverse Event Report: OPTIMIZED ORTHO PTY LTD OPTIMIZED POSITIONING SYSTEM

Model Number OPSINSIGHT

Device Problem Use of Device Problem (1670)

Patient Problem Inadequate Osseointegration (2646)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

We are currently in the process of retrieving further information to perform investigation. We will provide a follow up report upon completion. This report is filed with the fda due to an event experienced with a device that is same/similar to those placed on the market in the usa, however, this event occurred outside of the usa. Please note: the submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.

Event Description

Aug_rj_25482: surgeon suspected an infection for this patients hip replacement. After opening up he found the cup was loose and removed the cup and put another one.

• Brand Name: OPTIMIZED POSITIONING SYSTEM
• Type of Device: OPTIMIZED POSITIONING SYSTEM
• Manufacturer (Section D): OPTIMIZED ORTHO PTY LTD; 17 bridge street; pymble, nsw 2073 ; AS 2073
• Manufacturer (Section G): OPTIMIZED ORTHO PTY LTD; 17 bridge street; pymble, nsw 2073 ; AS 2073
• Manufacturer Contact: james tai ; 17 bridge street; pymble, nsw 2073 ; AS 2073
• MDR Report Key: 12472155
• MDR Text Key: 271471871
• Report Number: 3012916784-2021-00104
• Device Sequence Number: 1
• Product Code: PBF
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K192656
• 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,Followup
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: OPSINSIGHT
• Device Lot Number: AUG_RJ_25482
• Was Device Available for Evaluation?: No Answer Provided

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/06/2021
• Was Device Evaluated by Manufacturer?: No
• 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: 09/15/2021 Patient Sequence Number: 1

Treatment

OPS ACETABULAR GUIDE; OPS FEMORAL GUIDE