FDA.reportPublic FDA data

MAUDE MDR 9901389

MDR report key
9901389
Report number
1219602-2020-00569
Event key
0
Event type
3
Date of event
2020-02-07
Date received
2020-03-30
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
HOLLY TOPPING
Address
7000 WEST WILLIAM CANNON DRIVE AUSTIN TX 78735 US
Phone
512-512-5123
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AIMER ENDOFEMORAL 5MM OFFSET (RED)ACCESSORIES,ARTHROSCOPICSMITH & NEPHEW, INC.NBH7220171572201715UNKNOWN* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3001. O

Event Narratives#

N

Patient 1

(B)(6).

D

Patient 1

IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, METAL SHEDDINGS WERE SEEN COMING OFF IN THE JOINT. THIS WAS NOTICED IN THE FEMORAL TUNNEL WHILE THE OFFSET GUIDE WAS IN CONTACT WITH THE PASSING PIN. MOST OF THE METAL SHEDDINGS WERE REMOVED FROM THE KNEE JOINT WITH A MECHANICAL SHAVER. THE PROCEDURE WAS COMPLETED WITH THE SAME OFFSET GUIDE. THERE WAS NO SIGNIFICANT DELAY REPORTED. THE PATIENT'S OUTCOME IS AS EXPECTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.