MAUDE Adverse Event Report: OPTIMIZED ORTHO PTY LTD OPTIMIZED POSITIONING SYSTEM

Lot Number MEP_OE_19566

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/14/2020

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 the primary surgery was held on (b)(6) 2019.Where ops technology (ops plan with dha & acetabular & femoral guides) were used as assistive technology.However, recently the patient dislocated and the surgeon performing the revision surgery commented that there was little bone in-growth on the cup.The trinity cup was replaced with a stryker 50mm tritanium cup with screws and a constrained liner.Ops technology was not used for the revision surgery.

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 plan, dynamic hip analysis report, pre and post operative imaging of the patient, ops acetabular and femoral guides.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 acetabular or femoral guide.Dislocation after a total hip arthroplasty (tha) is influenced by multiple factors.These include the positioning of the acetabular component, the positioning of the femoral component, the anatomy of the patient, and the lifestyle of the patient post operation.As such, there are multiple factors that may have contributed to the dislocation which are outside the scope of this investigation.The dha report for this patient warns that the patient demonstrates a significant pelvic rotation of 14 degrees from supine to stand.Large pelvic rotations have been found in the literature to be a risk factor for dislocation.

Event Description

It was reported by a corin representative that the primary surgery was held on the (b)(6) 2019.Where ops technology (ops plan with dha & acetabular & femoral guides) were used as assistive technology.However, recently the patient dislocated and the surgeon performing the revision surgery commented that there was little bone in-growth on the cup.The trinity cup was replaced with a stryker 50mm tritanium cup with screws and a constrained liner.Ops technology was not used for the revision surgery.

• 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: 10377280
• MDR Text Key: 204766627
• Report Number: 3012916784-2020-00066
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K181061
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

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: MEP_OE_19566
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 08/06/2020
• Supplement Dates Manufacturer Received: 07/15/2020
• Supplement Dates FDA Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention