FDA.reportPublic FDA data

MAUDE MDR 9859442

MDR report key
9859442
Report number
3004105610-2020-00069
Event key
0
Event type
3
Date of event
2020-02-26
Date received
2020-03-20
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
MR. JOANN LAVATELLI
Address
325 CORPORATE DRIVE MAHWAH NJ 07430 US
Phone
201-201-2018
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PROXIMAL TIBIA JTSPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMERSTANMORE IMPLANTS WORLDWIDEKROUNK_STMPIN 20850R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2001. H; 2. R

Event Narratives#

N

Patient 1

AN INVESTIGATION IS BEING PERFORMED IN AN ATTEMPT TO IDENTIFY THE CAUSE OF THE EVENT.??SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. NOT RETURNED TO THE MANUFACTURER.

D

Patient 1

A PATIENT SPECIFIC PRESCRIPTION FORM WAS PROVIDED FOR THE PATIENT'S RIGHT PROXIMAL TIBIA WITH THE FOLLOWING INFORMATION: INDICATION/ DIAGNOSIS: LIMB LENGTH DISCREPANCY. REASON FOR REVISION: LIMB LENGTH DISCREPANCY, MUSCLE CONTRACTURE. NOTES: SAVE FEMORAL COMPONENT. THE OVERALL REPLACEMENT SHOULD COVER THE EXTENSION (~200-220 MM). ADDITIONAL INFORMATION PROVIDED BY THE REP: "THE PATIENT HAS A PAIN DURING THE KNEE EXTENSION AND A MUSCLE CONTRACTURE. THIS IS THE REASON THE IMPLANT CANNOT BE EXTENDED. THE ISSUE CANNOT BE SOLVED BY SHORTENING THE IMPLANT, THE SURGEON WISHES TO REPLACE THIS."