MAUDE Adverse Event Report: OPTIMIZED ORTHO PTY LTD CORIN OPTIMIZED POSITIONING SYSTEM; HIP PROSTHESIS, PRODUCT CODE: LZO

Model Number	1248-1500
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The ops acetabular patient specific guide was used during the primary surgery for a patient who was revised 1 year later due to psoas pain.It is unknown at this stage if the ops acetabular patient specific guide was used during primary surgery and therefore it is unknown if the ops acetabular patient specific guide might have contributed to this event.The manufacturer is conducting investigation to identify.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 or Problem Description
Patient underwent total hip replacement on the (b)(6) 2017.Patient required revision surgery due to psoas pain on the (b)(6) 2018.It was found on the (b)(6) 2018, that the patient received the ops acetabular guide during primary surgery.It is unknown if the ops acetabular guide was used during primary surgery.

• Brand Name: CORIN OPTIMIZED POSITIONING SYSTEM
• Common Device Name: HIP PROSTHESIS, PRODUCT CODE: LZO
• Manufacturer (Section D): OPTIMIZED ORTHO PTY LTD; 17 bridge street; pymble; sydney, nsw 2073 ; AS 2073
• MDR Report Key: 7745972
• Report Number: 3012916784-2018-00008
• Device Sequence Number: 11153307
• Product Code: LZO
• UDI-Device Identifier: 09351327000022
• UDI-Public: 9351327000022
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K152893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/03/2018

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
• Operator of Device: Health Professional
• Device Model Number: 1248-1500
• Device Lot Number: RIG_DF_7423H
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 08/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention