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

Lot Number SEL_RS_23828

Device Problems Fracture (1260); Use of Device Problem (1670)

Patient Problems Bone Fracture(s) (1870); Patient Problem/Medical Problem (2688)

Event Date 08/14/2020

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 patient developed periprosthetic fracture in pelvis post primary total hip replacement surgery.As a result, the trinity cup had to be revised to stryker restoration stem and tritanium dm cup.Surgeon did not cite implant failure as reason for revision and further information provided to us stated that the patient fell off a chair.Ops assistive technology was used in the primary surgery.Ops insight was used as the planning product along with acetabular and femoral guides.

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: all the relevant production manufacturing steps were completed correctly as per the relevant work instructions.The ops¿ insight analysis and the ops guides were developed according to specification.Further information provided to us stated that the patient fell off a chair.Ops did not cause or contribute to this revision event and it is likely the event occurred due to the patient fall.

Event Description

It was reported by a (b)(6) representative that the patient developed periprosthetic fracture in pelvis post primary total hip replacement surgery.As a result, the trinity cup had to be revised to stryker restoration stem and tritanium dm cup.Surgeon did not cite implant failure as reason for revision and further information provided to us stated that the patient fell off a chair.Ops assistive technology was used in the primary surgery.Ops insight was used as the planning product along with acetabular and femoral guides.

• 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: 10411965
• MDR Text Key: 204766956
• Report Number: 3012916784-2020-00068
• 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: 10/13/2020

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: SEL_RS_23828
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/14/2020
• Initial Date FDA Received: 08/16/2020
• Supplement Dates Manufacturer Received: 08/14/2020
• Supplement Dates FDA Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR