FDA.reportPublic FDA data

MAUDE MDR 9907836

MDR report key
9907836
Report number
1818910-2020-09797
Event key
0
Event type
3
Date of event
2020-03-03
Date received
2020-03-31
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
KARA DITTY-BOVARD
Address
700 ORTHOPAEDIC DRIVE WARSAW IN 46581 US
Phone
610-610-6107
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1UNKNOWN HIP FEMORAL STEMHIP FEMORAL STEMDEPUY ORTHOPAEDICS INC USKWAUNK HIP FEMORAL STEMR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. R

Event Narratives#

N

Patient 1

(B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR MANUFACTURING RECORD EVALUATION, WAS NOT POSSIBLE AS THE REQUIRED LOT NUMBER WAS NOT PROVIDED. THE INFORMATION RECEIVED WILL BE RETAINED FOR TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM.

D

Patient 1

IT WAS REPORTED THAT THE 60 X 36 PINNACLE LINER,13X18X160 SROM STEM,18 XXL SLEEVE 36 HEAD ALL REMOVED DUE TO LOOSENING. NO SURGICAL DELAY. DOI: 2016; DOR: (B)(6) 2020; RIGHT SIDE.