FDA.reportPublic FDA data

MAUDE MDR 9567562

MDR report key
9567562
Report number
0009613350-2020-00016
Event key
0
Event type
3
Date of event
2019-03-05
Date received
2020-01-09
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
1RASP SIZE 17N/AZIMMER GMBHHTRN/AUNKNOWNUNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-0901. R

Event Narratives#

N

Patient 1

THE MANUFACTURER RECEIVED X-RAYS AND OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE, AN UPDATED REPORT WILL BE SUBMITTED. (B)(4). ITEM AND LOT NUMBERS UNKNOWN.

D

Patient 1

IT WAS REPORTED THAT DURING REVISION SURGERY WHILE REAMING WITH A RASP A PERIPROSTHETIC FRACTURE OCCURRED RUNNING OUT DISTALLY, RESULTING IN A 2-LEVEL FRACTURE WITH A SPLIT OSTEOTOMY IN THE MIDDLE, WHICH IS REFIXED WITH CERCLAGE WIRES.