FDA.reportPublic FDA data

MAUDE MDR 5257039

MDR report key
5257039
Report number
1818910-2015-36154
Event key
0
Event type
3
Date of event
2015-07-02
Date received
2015-12-01
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
CHAD GIBSON
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 6.5MMX35MMHIP OTHER IMPLANTJOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043NDJ121735500D14111133R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-12-0101. R

Event Narratives#

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).

D

Patient 1

THE PATIENT'S MEDICAL RECORDS INDICATE THE PATIENT WAS REVISED TO ADDRESS AN INTRAPELVIC PROTRUSION AND PERIPROSTHETIC FRACTURE. UPON REVISION THE PATIENT'S ACETABULAR COMPONENT WAS FOUND TO BE COMPLETELY LOOSE. AT THIS TIME THE PATIENT'S CUP AND SCREWS ARE BEING REPORTED.

N

Patient 1

NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT/LOT COMBINATIONS INCE RELEASE FOR DISTRIBUTION. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.