MAUDE Adverse Event Report: OPTIMIZED ORTHO PTY LTD OPTIMIZED POSITIONING SYSTEM (OPS) INSIGHT; OPS INSIGHT

Lot Number SMA_AI_23219

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688)

Event Date 07/03/2020

Event Type  malfunction  

Manufacturer Narrative

We will provide a follow up report upon completion of our investigation.

Event Description

It was reported by a corin representative that there was a revision surgery due to dislocation after the primary surgery.The patient had the global cup with paragon stem implanted.During primary procedure, ops technology (ops insight with femoral guide) were employed as assistive technology.

Manufacturer Narrative

Method: no complaint devices were returned to optimized ortho by the customer.Thus, the device history files were investigated which included reviewing the ops insight, pre-imaging of the patient and all manufacturing steps of implant positioning and report generation were reviewed.Conclusion: according to the contact plot generated in ops insight there was no indication that the patient would dislocate at this orientation.However, the surgeon did not utilise an acetabular guide (no acetabular guide was booked, only a femoral guide was requested) which may have changed the achieved orientation intra-operatively.As no post-operative imaging was provided it is not possible to determine what orientation was achieved and how that contributed to the patient requiring a revision.This event predominantly occurred due to changes the surgeon made intra-operatively.All the relevant production manufacturing steps were completed correctly as per the relevant work instructions.

Event Description

It was reported by a corin representative that there was a revision surgery due to dislocation after the primary surgery.The patient had the global cup with paragon stem implanted.During primary procedure , ops technology (ops insight with femoral guide) were employed as assistive technology.

• Brand Name: OPTIMIZED POSITIONING SYSTEM (OPS) INSIGHT
• Type of Device: OPS INSIGHT
• Manufacturer (Section D): OPTIMIZED ORTHO PTY LTD; 17 bridge street; pymble, nsw 2073 ; AS 2073
• MDR Report Key: 10261873
• MDR Text Key: 204765823
• Report Number: 3012916784-2020-00062
• Device Sequence Number: 1
• Product Code: LZO
• 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: 09/02/2020

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 Lot Number: SMA_AI_23219
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 07/12/2020
• Supplement Dates Manufacturer Received: 07/07/2020
• Supplement Dates FDA Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OPS FEMORAL GUIDE (1250-0100); OPS FEMORAL GUIDE (1250-0100)
• Patient Outcome(s): Required Intervention