FDA.reportPublic FDA data

MAUDE MDR 9796581

MDR report key
9796581
Report number
0009613350-2020-00092
Event key
0
Event type
3
Date received
2020-03-06
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
1RESURFACING DUROM METASUL HEADRESURFACING DUROM METASUL HEADZIMMER GMBHKXAN/AUNKNOWNUNKNOWNN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-0601. H

Event Narratives#

N

Patient 1

CONCOMITANT MEDICAL PRODUCT: DUROM ACETABULAR COMPONENT; CATALOG NO#: UNKNOWN; LOT#: UNKNOWN. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. 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).

D

Patient 1

PATIENT WAS IMPLANTED RESURFACING DUROM METASUL HEAD AND EXPERIENCED PERIPROSTHETIC FRACTURE. IT IS UNKNOWN WHETHER REVISION TOOK PLACE.