FDA.reportPublic FDA data

MAUDE MDR 6897081

MDR report key
6897081
Report number
3002806535-2017-00909
Event key
0
Event type
3
Date of event
2016-09-25
Date received
2017-09-27
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
1HIPLOC COMPRESSION HIP SCREWDEVICE, FIXATIONBIOMET UK LTD.JDON/A2361252016040531Y N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-09-270

Event Narratives#

N

Patient 1

(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535 - 2017 - 00910.

D

Patient 1

IT IS REPORTED THAT THE LAG SCREW WOULD NOT GO THROUGH THE BARREL ON THE PLATE. THEREFORE, THE PLATE WAS NOT USE. ANOTHER PLATE AND LAG SCREW WERE USED INSTEAD. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.