MAUDE Adverse Event Report: OPTIMIZED ORTHO PTY LTD CORIN OPTIMIZED POSITIONING SYSTEM; HIP PROSTHESIS

Model Number 1248_0500

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Patient Problem/Medical Problem (2688)

Event Date 01/23/2020

Event Type  Injury  

Manufacturer Narrative

Patient underwent primary procedure on the (b)(6) 2019.Patient complained of pain and it was found that the cup went loose with no bony fixation.Therefore, patient was revised for cup loosening on the (b)(6) 2020.Patient complained of pain, cup was found to be loose with no bony.This report is filed with the fda due to an event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.

Event Description

Patient underwent primar procedure on the (b)(6) 2019.Patient complained of pain and it was found that the cup went loose with no bony fixation.Therefore, patient was revised for cup loosening on the (b)(6) 2020.Patient complained of pain, cup was found to be loose with no bony.The event occured in (b)(6).This report is filed with the fda due to an event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.

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, pre-operative imaging, manufacturing steps of implant positioning and report generation.Results:.The implants were processed on scan ip and were carried out as per opt-wki-mf-68.Review of the data shows that implant provided adequate fixation anteriorly, posteriorly and superiorly and was not found to be undersized.Conclusion: the implants for this case satisfy the current work instructions and were planned appropriately.We are unable to identify any internal issues with this case.It is likely that other factors or patient conditions may have led the cup to become loose.Please note: the submission of this report does not constitute and admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.

Event Description

Loose with no bony fixation.Therefore, patient was revised for cup loosening on the (b)(6) 2020.Patient complained of pain, cup was found to be loose with no bony fixation.The event occured in australia.This report is filed with the fda due to an event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.

• Brand Name: CORIN OPTIMIZED POSITIONING SYSTEM
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): OPTIMIZED ORTHO PTY LTD; 17 bridge street; pymble; pymble, nsw 2073 ; AS 2073
• MDR Report Key: 9679706
• MDR Text Key: 186831951
• Report Number: 3012916784-2020-00052
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K152893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1248_0500
• Device Lot Number: RIT_MO_18565
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention