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

Lot Number THO_MO_19901

Device Problems Loose or Intermittent Connection (1371); Use of Device Problem (1670)

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

Event Date 08/06/2020

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 stress fracture in pelvis post primary total hip replacement surgery.As a result, the trinity cup had to be revised to trinity plus due to loosening.The surgeon believes it was related to overuse or the patient returned to too much activity too quickly.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 workinstructions.The ops¿ insight analysis and the ops guides were developed according to specifications and the cause of the cup loosening was not determined.The surgeon did note that the patient may have returned to strenuous physical activity too early after the primary total hip replacement which can contribute to the loosening of the cup and the stress fracture.Ops did not cause or contribute to this revision event.

Event Description

It was reported by a corin representative that the patient developed stress fracture in pelvis post primary total hip replacement surgery.As a result, the trinity cup had to be revised to trinity plus due to loosening.The surgeon believes it was related to overuse or the patient returned to too much activity too quickly.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: 10400144
• MDR Text Key: 204766720
• Report Number: 3012916784-2020-00067
• 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: 10/08/2020

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: THO_MO_19901
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 08/13/2020
• Supplement Dates FDA Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR