FDA.reportPublic FDA data

MAUDE MDR 9882507

MDR report key
9882507
Report number
0001825034-2020-01038
Event key
0
Event type
3
Date of event
2020-02-26
Date received
2020-03-26
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
1JGRKNT 1.0MM MINI 2-0 NDLSPROSTHESIS, SPORTSMEDZIMMER BIOMET, INC.MBIN/A912076NIR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-260

Event Narratives#

N

Patient 1

(B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# 912076; JGRKNT 1.0MM MINI 2-0 NDLS; LOT# UNKNOWN. (B)(6). 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-01037.

D

Patient 1

IT WAS REPORTED THAT DURING THE SURGERY, THE CLEAR SLEEVE OF THIS PRODUCT DIDN'T MOVE SMOOTHLY. SO, THE SURGEON COULDN'T USE THIS PRODUCT FOR THE SURGERY. THEREFORE, HE USED AN ALTERNATIVE PRODUCT TO COMPLETE THE SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.