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 07/08/2021

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

(b)(): patient came back with signs of infection and dr.(b)(6) removed all implants washed out the joint and re-implanted new implants.

Event Description

(b)(6) : patient came back with signs of infection and dr.(b)(6) removed all implants washed out the joint and re-implanted new implants.

Manufacturer Narrative

No complaint devices were returned to optimized ortho by the customer.Thus, the device processing files were investigated which included reviewing ops processes, ops acetabular and femoral guides, and pre and post operative imaging of the patient.The design of patient specific guides have been determined to be unrelated to the failure mode of infection.The intended moist heat sterilisation method for sterilising the ops patient specific instruments has been validated to achieve sal 10-6 as per iso17665-1, as per opt-rsk-16 v111.There was no evidence to suggest that the ops technology provided to the primary surgery malfunctioned or was deficient.This failure mode is not associated with the use of ops technology in the primary surgery.There is no evidence to suggest that the use of ops technology in the primary surgery contributed to this revision event.Therefore the case is now considered closed.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.

• 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
• MDR Report Key: 12376177
• MDR Text Key: 268451258
• Report Number: 3012916784-2021-00102
• Device Sequence Number: 1
• Product Code: PBF
• Combination Product (y/n): N
• PMA/PMN Number: K192656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OPSINSIGHT
• Device Lot Number: YVD_WR_47406
• Date Manufacturer Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OPS ACETABULAR GUIDE; OPS ACETABULAR GUIDE; OPS FEMORAL GUIDE; OPS FEMORAL GUIDE; OPS ACETABULAR GUIDE; OPS FEMORAL GUIDE
• Patient Outcome(s): Required Intervention