CORIN OPTIMIZED POSITIONING SYSTEM 1248-0500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for CORIN OPTIMIZED POSITIONING SYSTEM 1248-0500 manufactured by Optimized Ortho Pty Ltd.

Event Text Entries

[187590539] We are currently in the process of obtaining further information and complete the root cause investigation. The final report will be sent upon closure of root cause 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.
Patient Sequence No: 1, Text Type: N, H10


[187590540] It was reported by a corin representative that there was a revision due to leg length discrepancy after the primary surgery. The patient had the trinity cup system with metax stem implanted. During primary procedure , ops technology (ops plan with dha & acetabular & femoral guide) were employed as assistive technology.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012916784-2020-00057
MDR Report Key9908770
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-04-01
Date Mfgr Received2020-03-04
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS SIMRAT GILL
Manufacturer Street17 BRIDGE STREET
Manufacturer CityPYMBLE, NSW 2073
Manufacturer CountryAS
Manufacturer Postal2073
Manufacturer G1OPTIMIZED ORTHO PTY LTD
Manufacturer Street17 BRIDGE STREET
Manufacturer CityPYMBLE, NSW 2073
Manufacturer CountryAS
Manufacturer Postal Code2073
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCORIN OPTIMIZED POSITIONING SYSTEM
Generic NameHIP PROSTHESIS
Product CodeLZO
Date Received2020-03-31
Model Number1248-0500
Lot NumberSHE_PY_22314
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOPTIMIZED ORTHO PTY LTD
Manufacturer Address17 BRIDGE STREET PYMBLE, NSW 2073 AS 2073


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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