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

Model Number	1248-0500
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cc-196 - initial report.The design history records of the ops acetabular guide have been retrieved, post operative imaging has been provided.These are currently under assessment by the manufacturer.The outcome of the assessment will be presented in the final report.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.Please note: the submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.
Event or Problem Description
Patient dislocated 1 week following primary total hip replacement (while still in hospital).It was reported by the surgeon representative to be an anterior dislocation.Patient was revised.The primary total hip replacement surgery was performed with the assistance of the ops technologies which include ops acetabular and femoral patient specific guides, dynamic hip analysis and ops plan pre operative reports.The surgeon reported that the ops acetabular guide was a good fit to the patient acetabulum.
Event or Problem Description
Cc-196 final report: initial report was submitted under reference mfr# 3012916784-2019-00013.Patient dislocated 1 week following primary total hip replacement (while still in hospital).It was reported by the surgeon representative to be an anterior dislocation.Patient was revised.The primary total hip replacement surgery was performed with the assistance of the ops technologies which include ops acetabular and femoral patient specific guides, dynamic hip analysis and ops plan pre-operative reports.The surgeon reported that the ops acetabular guide was a good fit to the patient acetabulum.The manufacturer has now conducted a full investigation into this case.The results of this investigation indicated no obvious cause for the dislocation of the patient.No issue was found with the product provided to the surgeon.
Additional Manufacturer Narrative
Cc-196 final report: initial report was submitted under reference mfr# 3012916784-2019-00013.The design history records of the ops acetabular guide have been retrieved, post operative imaging has been provided.These were assessed by the manufacturer.The outcome of this assessment showed no issue with the product provided to the primary surgery, and that there was no evidence in the processing of the case that the use of ops technology would have contributed to the occurrence of this adverse event.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.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; pymble, 2073 ; AS 2073
• MDR Report Key: 8415766
• Report Number: 3012916784-2019-00013
• Device Sequence Number: 13772553
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2019

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
• Operator of Device: Health Professional
• Device Model Number: 1248-0500
• Device Catalogue Number: N/A
• Device Lot Number: JOR_WB_14770
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 05/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR