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 08/18/2021

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.

Event Description

(b)(6): stem to be removed as patient was not happy with leg length discrepancy.

Manufacturer Narrative

Optimized ortho launched an investigation into this event.No complaint devices were returned to optimized ortho by the customer.Thus, the device history were investigated which included reviewing ops processes, ops acetabular and femoral guides, and pre and post operative imaging of the patient.All manufacturing steps of implant positioning and report generation were reviewed.All operations were completed correctly according to the work instructions.No deficiency was found with any of the ops related process or ops acetabular and femoral guides.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.

Event Description

(b)(6) : stem to be removed as patient was not happy with leg length discrepancy.

• 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: 12376172
• MDR Text Key: 280898003
• Report Number: 3012916784-2021-00101
• 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

• 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: DEL_GP_26486
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 08/27/2021
• Supplement Dates Manufacturer Received: 08/23/2021
• Supplement Dates FDA Received: 10/10/2021
• 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
• Patient Outcome(s): Required Intervention