MAUDE Adverse Event Report: OPTIMIZED ORTHO PTY LTD CORIN OPTIMIZED POSITIONING SYSTEM; HIP PROSTHESIS

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The manufacturer is conducting investigation to identify root cause of this event.The issue was identified prior point of use of the device.Therefore, there is no impact to the safety of patient and user.This report is filed with the fda due to an event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.

Event Description

The dha report (product not available in the us , but is similar to the one placed in the us market ) was generated with the 9 orientation plots belonging to a different patient.The issue was detected prior to use.Therefore, there was no impact for patient or user of the device.

• Brand Name: CORIN OPTIMIZED POSITIONING SYSTEM
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): OPTIMIZED ORTHO PTY LTD; 17 bridge street; pymble; sydney, nsw 2073 ; AS 2073
• Manufacturer (Section G): OPTIMIZED ORTHO PTY LTD; 17 bridge street; pymble; sydney, nsw 2073 ; AS 2073
• Manufacturer Contact: martina cecconi ; 17 bridge street; pymble; sydney, nsw 2073 ; AS 2073
• MDR Report Key: 7644495
• MDR Text Key: 112886983
• Report Number: 3012916784-2018-00007
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K152893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: BRY_MS_11643
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/30/2018
• Initial Date FDA Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1