FDA.reportPublic FDA data

MAUDE MDR 4598449

MDR report key
4598449
Report number
1818910-2015-16084
Event key
0
Event type
3
Date of event
2015-02-23
Date received
2015-03-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
STEVE DOWELL
Address
700 ORTHOPAEDIC DRIVE WARSAW IN 46581 US
Phone
574-574-5743
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PINN CAN BONE SCREW 6.5MMX30MMHIP OTHER IMPLANTDEPUY ORTHOPAEDICS, INC. 1818910NDJ121730500D13124102R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-03-1301. R

Event Narratives#

N

Patient 1

THE COMPLAINT STATES PATIENT WAS REVISED TO ADDRESS ACETABULAR CUP LOOSENING. IT WAS NOTED THAT THE CUP HAD BECOME LOOSE DUE TO A HOLE ON THE ANTERIOR MEDIAL SIDE OF THE CUP. A COMPLAINTS DATABASE SEARCH AND REVIEW OF MANUFACTURING RECORDS DID NOT IDENTIFY ANY ANOMALIES. WITHOUT FURTHER INFORMATION OR RETURN OF PRODUCTS THE ROOT CAUSE OF THE COMPLAINT CANNOT BE CONFIRMED. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION AND ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS. IF FURTHER INFORMATION IS RECEIVED THE COMPLAINT SHALL BE REOPENED AND INVESTIGATED FURTHER. NO FURTHER ACTIONS ARE IDENTIFIED. POST MARKET SURVEILLANCE IS PER (B)(4).

D

Patient 1

PATIENT WAS REVISED TO ADDRESS ACETABULAR CUP LOOSENING. IT WAS NOTED THAT THE CUP HAD BECOME LOOSE DUE TO A HOLE ON THE ANTERIOR MEDIAL SIDE OF THE CUP.

N

Patient 1

THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).