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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OPTIMIZED ORTHO PTY LTD OPTIMIZED POSITIONING SYSTEM

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OPTIMIZED ORTHO PTY LTD OPTIMIZED POSITIONING SYSTEM Back to Search Results
Model Number OPSINSIGHT
Device Problem Use of Device Problem (1670)
Patient Problem Inadequate Osseointegration (2646)
Event Date 08/18/2021
Event Type  malfunction  
Manufacturer Narrative
We are currently in the process of retrieving further information to perform investigation.We will provide a follow up report upon completion.This report is filed with the fda due to an event experienced with a device that is same/similar to those placed on the market in the usa, however, this event occurred outside of the usa.
 
Event Description
(b)(6): stem to be removed as patient was not happy with leg length discrepancy.
 
Manufacturer Narrative
Optimized ortho launched an investigation into this event.No complaint devices were returned to optimized ortho by the customer.Thus, the device history were investigated which included reviewing ops processes, ops acetabular and femoral guides, and pre and post operative imaging of the patient.All manufacturing steps of implant positioning and report generation were reviewed.All operations were completed correctly according to the work instructions.No deficiency was found with any of the ops related process or ops acetabular and femoral guides.There is no evidence to suggest that the use of ops technology in the primary surgery contributed to this revision event.Therefore the case is now considered closed.This report is filed with the fda due to an event experienced with a device that is same/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 Description
(b)(6) : stem to be removed as patient was not happy with leg length discrepancy.
 
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Brand Name
OPTIMIZED POSITIONING SYSTEM
Type of Device
OPTIMIZED POSITIONING SYSTEM
Manufacturer (Section D)
OPTIMIZED ORTHO PTY LTD
17 bridge street
pymble, nsw 2073
AS  2073
MDR Report Key12376172
MDR Text Key280898003
Report Number3012916784-2021-00101
Device Sequence Number1
Product Code PBF
Combination Product (y/n)N
PMA/PMN Number
K192656
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 08/27/2021
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
Device Operator Health Professional
Device Model NumberOPSINSIGHT
Device Lot NumberDEL_GP_26486
Initial Date Manufacturer Received 08/23/2021
Initial Date FDA Received08/27/2021
Supplement Dates Manufacturer Received08/23/2021
Supplement Dates FDA Received10/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
OPS ACETABULAR GUIDE; OPS ACETABULAR GUIDE; OPS FEMORAL GUIDE; OPS FEMORAL GUIDE
Patient Outcome(s) Required Intervention;
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