FDA.reportPublic FDA data

MAUDE MDR 9672279

MDR report key
9672279
Report number
0001825034-2020-00490
Event key
0
Event type
3
Date of event
2020-01-07
Date received
2020-02-05
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
1PARTIAL TIBIAL CEMENTED SIZE F LEFT MEDIALPROSTHESIS, KNEEZIMMER BIOMET, INC.HSXN/A4253800060164271273R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-0501. O

Event Narratives#

N

Patient 1

(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REPORT SOURCE: EVENT OCCURRED IN (B)(6).

D

Patient 1

IT WAS REPORTED THAT APPROXIMATELY 1 MONTH POST IMPLANTATION, THE PATIENT EXPERIENCED PAIN AND WAS FOUND TO HAVE A TIBIAL BONE FRACTURE. THE PATIENT HAS INDICATED A POSSIBLE REVISION, BUT ONE HAS NOT BEEN CONFIRMED YET. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.