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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 1248-1100
Device Problems Compatibility Problem (2960); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/16/2019
Event Type  malfunction  
Manufacturer Narrative
The patient specific femoral guide (k181061) was reported to indicate an osteotomy level that resulted in the lt distance being 10mm, when a lt distance of 5mm had been planned pre-operatively.The risk of sub-optimal osteotomy level is considered to be a risk of serious injury or adverse event for the patient.Post-operative imaging has been requested from the reporter to confirm the effect of this issue on the patient.No adverse event or reintervention has been reported for this patient.
 
Event Description
The patient specific femoral guide (k181061) was reported to indicate an osteotomy level that resulted in the lt distance being 10mm, when a lt distance of 5mm had been planned pre-operatively.The risk of sub-optimal osteotomy level is considered to be a risk of serious injury or adverse event for the patient.Post-operative imaging has been requested from the reporter to confirm the effect of this issue on the patient.No adverse event or reintervention has been reported for this patient.
 
Event Description
The patient specific femoral guide (k181061) was reported to indicate an osteotomy level that resulted in the lt distance being 10mm, when a lt distance of 5mm had been planned pre-operatively.The risk of sub-optimal osteotomy level is considered to be a risk of serious injury or adverse event for the patient.Post-operative imaging has been requested from the reporter to confirm the effect of this issue on the patient.No adverse event or reintervention has been reported for this patient.A root cause investigation has now been conducted into this event.The femoral guide was designed to the correct production process, adhering to the relevant work instruction.The case was reprocessed correctly and the right distance from the lower trochanter was calculated.The femoral guide was then designed based on this resection and was sent to the external supplier materialise to be printed.Materialise has also confirmed that the correct stem femoral guide was printed and sent.As it has been determined that the products involved in this complaint accurately and correctly followed the steps laid out in the relevant wkis, it is likely that the root cause of this occurred out of the control of internal process, and as such no root cause could be identified.
 
Manufacturer Narrative
The patient specific femoral guide (k181061) was reported to indicate an osteotomy level that resulted in the lt distance being 10mm, when a lt distance of 5mm had been planned pre-operatively.The risk of sub-optimal osteotomy level is considered to be a risk of serious injury or adverse event for the patient.Post-operative imaging has been requested from the reporter to confirm the effect of this issue on the patient.No adverse event or reintervention has been reported for this patient.A root cause investigation has now been conducted into this event.The femoral guide was designed to the correct production process, adhering to the relevant work instruction.The case was reprocessed correctly and the right distance from the lower trochanter was calculated.The femoral guide was then designed based on this resection and was sent to the external supplier materialise to be printed.Materialise has also confirmed that the correct stem femoral guide was printed and sent.As it has been determined that the products involved in this complaint accurately and correctly followed the steps laid out in the relevant wkis, it is likely that the root cause of this occurred out of the control of internal process, and as such no root cause could be identified.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.
 
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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 Key9579571
MDR Text Key204764115
Report Number3012916784-2020-00042
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,other
Type of Report Initial,Followup
Report Date 02/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1248-1100
Device Lot NumberBAY_WR_19293
Was Device Available for Evaluation? No
Date Manufacturer Received12/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age79 YR
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