FDA.reportPublic FDA data

MAUDE MDR 9817255

MDR report key
9817255
Report number
9616494-2018-00063
Event key
0
Event type
3
Date of event
2018-04-03
Date received
2020-03-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. DOMINIK SCHMIDT
Address
MAX-NAEDER-STR. 15 DUDERSTADT, NIEDERSACHSEN 37115 GM
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MODULAR POLYCENTRIC EBS KNEE JOINTMODULAR POLYCENTRIC EBS KNEE JOINTOTTO BOCK HEALTHCARE GMBHISY3R603R60Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-110

Event Narratives#

N

Patient 1

THE VISUAL EVALUATION SHOWED THAT TWO OF THE UPPER BOLTS WERE LOOSE. NO FALL OR INJURY OCCURRED DUE TO THIS FAILURE, BUT IT COULD HAVE LED TO PATIENT INJURY.

D

Patient 1

KNEE JOINT WAS SENT IN FOR REPAIR. ACCORDING TO INFORMATION PROVIDED BY THE CUSTOMER ONE SCREW STRIPPED OUT OF 4 BAR SYSTEM (TOP OF KNEE ON THE FLEXION ADJUSTMENT SIDE) NO FALL, NO INJURIES.