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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OPTIMIZED ORTHO PTY LTD CORIN OPTIMIZED POSITIONING SYSTEM; HIP PROSTHESIS
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OPTIMIZED ORTHO PTY LTD CORIN OPTIMIZED POSITIONING SYSTEM; HIP PROSTHESIS Back to Search Results
Model Number 1250-1100
Device Problems Fitting Problem (2183); No Apparent Adverse Event (3189)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 01/07/2020
Event Type  malfunction  
Manufacturer Narrative
The patient specific femoral guide (k181061) was reported to be poor fitting.The surgeon proceeded with the use of the guide and made adjustments to compensate for poor fit.Information provided with the patient specific guides indicate for surgeons to abandon the use of the guides if they do not fit.There is no evidence that further intervention has been required for this patient.Additional information, including a post-operative ct imaging of the hip has been requested for this patient in order to measure the osteotomy level to determine whether there has been any impact to the patient, and if received, will be provided in a supplemental report upon completion of the investigation.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
The patient specific femoral guide (k181061) was reported to be poor fitting.The surgeon proceeded with the use of the guide and made adjustments to compensate for poor fit.Information provided with the patient specific guides indicate for surgeons to abandon the use of the guides if they do not fit.There is no evidence that further intervention has been required for this patient.Additional information, including a post-operative ct imaging of the hip has been requested for this patient in order to measure the osteotomy level to determine whether there has been any impact to the patient, and if received, will be provided in a supplemental report upon completion of the investigation.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 les were investigated which included reviewing the ops femoral guide design, pre-operative imaging all production steps of the femoral guide.Results: the femoral guide was designed to the correct production process, adhering to the relevant procedures and work instructions.The segmentation and land marking was accurate.The implant positioning was within speciations.As it has been determined that the products involved in this complaint accurately and correctly followed the steps laid out in the relevant procedures.It is likely that the root cause of this customer complaint was out of the control of internal process, and could have been a result of factors such as poor placement of the femoral guide on the femur intra-operatively.Conclusion: the femoral guide for this case was generated correctly and was within all speciations as described in internal procedures.It was found that the likely root cause of this customer complaint was out of the control of internal processes 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.
 
Event Description
The patient specific femoral guide (k181061) was reported to be poor fitting.The surgeon proceeded with the use of the guide and made adjustments to compensate for poor fit.Information provided with the patient specific guides indicate for surgeons to abandon the use of the guides if they do not fit.There is no evidence that further intervention has been required for this patient.Additional information, including a post-operative ct imaging of the hip has been requested for this patient in order to measure the osteotomy level to determine whether there has been any impact to the patient, and if received, will be provided in a supplemental report upon completion of the investigation.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.
 
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Brand Name
CORIN OPTIMIZED POSITIONING SYSTEM
Type of Device
HIP PROSTHESIS
Manufacturer (Section D)
OPTIMIZED ORTHO PTY LTD
17 bridge street
pymble, nsw 2073
AS  2073
MDR Report Key9614466
MDR Text Key204762608
Report Number3012916784-2020-00046
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
PMA/PMN Number
K181061
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 05/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1250-1100
Was Device Available for Evaluation? No
Date Manufacturer Received01/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age59 YR
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