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

Model Number	1248-1500
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/10/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was identified that there was an error with the supine pelvic tilt measurement which has resulted in the ops acetabular guide being manufactured with the incorrect orientation.
Additional Manufacturer Narrative
Resubmission of as a follow up -1 to 2916784-2017-00001.Additional information, including a post-operative a-p pelvic x-ray were obtained for this patient in order to measure the acetabular cup orientation to determine whether there has been any impact to the patient.It was found a deviation of approx 10° in acetabular cup inclination.There is no evidence that further intervention has been required for this patient.It was found that the cause of the incorrect orientation was multifactorials including pre-populated working template and lagging of the system.To reduce the risk of reoccurrence of this event the calculator script is updated to introduce error handling notification.Based on this, optimized ortho now consider this case closed.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.

• Brand Name: CORIN OPTIMIZED POSITIONING SYSTEM
• Common Device Name: HIP PROSTHESIS
• Manufacturer (Section D): OPTIMIZED ORTHO PTY LTD.; 17 bridge street; pymble, nsw 2073 ; AS 2073
• Manufacturer (Section G): OPTIMIZED ORTHO PTY LTD.; 17 bridge street; pymble, nsw 2073 ; AS 2073
• Manufacturer Contact: martina cecconi ; 17 bridge street; pymble, nsw 2073 ; AS 2073
• MDR Report Key: 20660391
• Report Number: 3012916784-2018-00006
• Device Sequence Number: 12814056
• Product Code: LZO
• UDI-Device Identifier: 09351327000022
• UDI-Public: 9351327000022
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K152893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1248-1500
• Device Lot Number: CON_SR_7066H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown