FDA.reportPublic FDA data

MAUDE MDR 4588955

MDR report key
4588955
Report number
1818910-2015-15842
Event key
0
Event type
3
Date of event
2015-02-22
Date received
2015-03-11
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 6.5MMX15MMHIP OTHER IMPLANTJOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.3006356043NDJ121715500D14040092R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-03-1101. R

Event Narratives#

D

Patient 1

PATIENT WAS REVISED TO ADDRESS INFECTION.

N

Patient 1

ADDITIONAL NARRATIVE: 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).

N

Patient 1

THE COMPLAINT STATES PATIENT WAS REVISED TO ADDRESS INFECTION. A COMPLAINTS DATABASE SEARCH AND REVIEW OF MANUFACTURING RECORDS DID NOT IDENTIFY ANY ANOMALIES. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION IT WILL BE ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS.