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

Lot Number BIR_DR_23213

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 07/09/2020

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 trinity cup system with taperfit stem implanted.During primary procedure , ops technology (ops insight with femoral guide) were employed as assistive technology.

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 trinity cup system with taperfit 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 plan, pre-operative imaging of the patient and all manufacturing steps of implant positioning and report generation were reviewed.Conclusion: all operations were completed correctly according to the work instructions.No deficiency was found with any of the ops related processes or the femoral guide.As it has been determined that the products involved in this complaint accurately and correctly followed the steps laid out in the relevant ops production processes, it is likely that the root cause of this customer complaint was out of the control of internal process, and could have been a result of factors such as the surgeon changing the liner intraoperatively to the dual mobility.

• 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: 10261872
• MDR Text Key: 204766169
• Report Number: 3012916784-2020-00061
• 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: 09/04/2020

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: BIR_DR_23213
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 07/12/2020
• Supplement Dates Manufacturer Received: 07/10/2020
• Supplement Dates FDA Received: 09/03/2020
• 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