FDA.reportPublic FDA data

MAUDE MDR 6305768

MDR report key
6305768
Report number
0001825034-2017-00478
Event key
0
Event type
3
Date of event
2017-01-09
Date received
2017-02-06
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
1BIOMET ILOK STEM TIB TRAY 67MMPROTHESIS, KNEEBIOMET ORTHOPEDICSMBVN/A141512944320Y N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-02-0601. H; 2. R

Event Narratives#

N

Patient 1

CONCOMITANT MEDICAL PRODUCTS: ITEM NAME: E1 VNGD AS TIB BRG 10X63, ITEM NUMBER: EP-189020, LOT NUMBER: 225960. ITEM NAME: BIOMET TIB BLOCK 6MM 67, ITEM NUMBER: 141742, LOT NUMBER: 930680. THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001825034-2017-00480/00481).

D

Patient 1

IT WAS REPORTED THE PATIENT WAS REVISED FOR TIBIAL LOOSENING.

N

Patient 1

REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.