FDA.reportPublic FDA data

MAUDE MDR 8481440

MDR report key
8481440
Report number
0009613350-2019-00186
Event key
0
Event type
3
Date of event
2017-12-29
Date received
2019-04-04
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
1SULOX HEAD, M, 32/0, TAPER 12/14N/AZIMMER GMBHKWBN/AUNKNOWNUNKNOWNN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-0401. H; 2. R

Event Narratives#

N

Patient 1

THE MANUFACTURER DID NOT RECEIVE X-RAYS BUT RECEIVED 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT 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. ZIMMER BIOMET?S REFERENCE NUMBER OF THIS FILE IS (B)(4). PRODUCT REFERENCE UNKNOWN.

D

Patient 1

IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN. DURING THE REVISION SURGERY IT WAS NOTICED THAT THE IMPLANTED HEAD WAS BROKEN INTO AT LEAST FIVE PIECES.