FDA.reportPublic FDA data

MAUDE MDR 6864204

MDR report key
6864204
Report number
0001822565-2017-06372
Event key
0
Event type
3
Date of event
2011-10-11
Date received
2017-09-14
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
1GENDER SOLUTIONS PATELLO-FEMORAL TROCHLEA COMPONENTPROSTHESIS, KNEEZIMMER BIOMET, INC.KRRN/A0059260130161408743R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-09-1401. H; 2. R

Event Narratives#

N

Patient 1

(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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.

D

Patient 1

IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS LOOSENING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

N

Patient 1

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: CONCOMITANT DEVICES - UNKNOWN ZIMMER TIBIAL COMPONENT CATALOG #: NI LOT #: NI, UNKNOWN ZIMMER ARTICULAR SURFACE CATALOG #: NI LOT #: NI THE PRODUCT WAS EVALUATED THROUGH REVIEW OF MANUFACTURING RECORDS, HOWEVER THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. PER THE PACKAGE INSERT FOR THE GENDER SOLUTIONS PATELLO-FEMORAL JOINT, LOOSENING IS ONE OF THE ADVERSE EFFECTS OF TOTAL KNEE ARTHROPLASTY. HOWEVER, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT; PLEASE SEE ALL REPORTS ASSOCIATED WITH THIS EVENT. 0001822565-2017-06372 0001822565-2018-04856

D

Patient 1