FDA.reportPublic FDA data

MAUDE MDR 8152066

MDR report key
8152066
Report number
0001825034-2018-11196
Event key
0
Event type
3
Date of event
2018-11-10
Date received
2018-12-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. CHRISTINA ARNT
Address
56 E. BELL DR. WARSAW IN 46582 US
Phone
574-574-5745
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ULTRA DRIVE TIP EXTENDERINSTRUMENT, HIPZIMMER BIOMET, INC.JDXN/A423838688070R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-110

Event Narratives#

N

Patient 1

(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS DISCARDED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 423871 ULTRA DRIVE DISK DRILL, 186730. 423836 ULTRA DRIVE TIP EXTENDER, 434510. 423872 ULTRA DRIVE DISK DRILL, 112350. 423873 ULTRA DRIVE DISK DRILL, 078290. 423874 ULTRA DRIVE DISK DRILL, 716550. 423836 ULTRA DRIVE TIP EXTENDER, 123460.

D

Patient 1

IT WAS REPORTED THAT DURING A HIP ARTHROPLASTY THE INSTRUMENT BROKE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.