FDA.reportPublic FDA data

MAUDE MDR 9908770

MDR report key
9908770
Report number
3012916784-2020-00057
Event key
0
Event type
3
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS SIMRAT GILL
Address
17 BRIDGE STREET PYMBLE, NSW 2073 AS
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CORIN OPTIMIZED POSITIONING SYSTEMHIP PROSTHESISOPTIMIZED ORTHO PTY LTDLZO1248-0500SHE_PY_22314R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. R

Event Narratives#

N

Patient 1

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.

D

Patient 1

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.