FDA.reportPublic FDA data

MAUDE MDR 7322571

MDR report key
7322571
Report number
2027111-2018-00081
Event key
0
Event type
3
Date of event
2018-02-06
Date received
2018-03-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US
Phone
949-949-9497
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HR005, M/L ALEXIS ORTHO PROT 5/BXKGWAPPLIED MEDICAL RESOURCESKGWHR0051014289011305916R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-03-070

Event Narratives#

N

Patient 1

NO PRODUCT IS BEING RETURNED FOR EVALUATION, BUT A LOT # IS PROVIDED. A DEVICE HISTORY REPORT IS TO BE REVIEWED BY ENGINEERING. A FINAL REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED.

D

Patient 1

PROCEDURE PERFORMED: "TOTAL HIP ARTHROPLASTY." EVENT DESCRIPTION: "[SURGEON] FROM (B)(6) HOSPITAL WAS DOING A TOTAL HIP ARTHROPLASTY (POSTERIOR APPROACH) DURING THE END OF THE CASE WHEN HE WAS PUTTING IN THE FEMORAL IMPLANT, IT GOT CAUGHT ON THE ALEXIS UNBEKNOWNST TO HIM AN THE STAFF. WHEN [SURGEON] TRIED TO REMOVE THE ALEXIS AFTER THE IMPLANTS WERE PLACED, HE NOTICED THAT THE FEMORAL IMPLANT WAS CAUGHT ON THE ALEXIS. THIS REQUIRED [SURGEON] TO HAVE TO CUT THE ALEXIS FROM THE IMPLANT AND THEN REMOVE THE IMPLANT TO REMOVE THE TORN PIECE OF ALEXIS THAT WAS CAUGHT IN IT. HAVING THE ALEXIS CAUGHT IN THE IMPLANT MADE HIM WEARY OF THE DEVICE BECAUSE HE HADN'T NOTICED IT, THERE COULD'VE BEEN A PIECE OF THE ALEXIS LEFT IN THR PATIENT." TYPE OF INTERVENTION: "THIS REQUIRED [SURGEON] TO HAVE TO CUT THE ALEXIS FROM THE IMPLANT AND THEN REMOVE THE IMPLANT TO REMOVE THE TORN PIECE OF ALEXIS THAT WAS CAUGHT IN IT." PATIENT STATUS: "NO PATIENT INJURY."