FDA.reportPublic FDA data

MAUDE MDR 4610041

MDR report key
4610041
Report number
1818910-2015-16317
Event key
0
Event type
3
Date of event
2015-03-02
Date received
2015-03-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. KARA DITTY-BOVARD
Address
700 ORTHOPAEDIC DRIVE WARSAW IN 46581 US
Phone
610-610-6103
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 USNDJ121730500YS5JG1000R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-03-1701. R

Event Narratives#

D

Patient 1

PATIENT WAS REVISED TO ADDRESS PAIN AND BLACK STAINING OF THE TISSUES.

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).

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.

D

Patient 1

UPDATE REC'D 03/23/2015 - THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. ACCORDING TO THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS INCREASING PAIN. UPON REVISION METALLOSIS, BLACK SYNOVIAL TISSUE, AND A CYST IN THE GREATER TROCHANTER WERE FOUND. ALSO NOTED, ONE OF THE SCREWS IN THE ACETABULUM WAS PROMINENT BUT THERE WAS NO INDICATION OF WEAR ON THE BACKSIDE OF THE LINER, THE SCREW WAS REMOVED.

N

Patient 1

NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE FOR THE UNKNOWN LOT CODE(S). 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 AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

N

Patient 1

DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

D

Patient 1

UPDATE REC?D 05/18/2016 - LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALSO ALLEGES THE PATIENT SUFFERS FROM ELEVATED METAL IONS, METAL DEBRIS, AND LIMITED MOBILITY. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. UPDATED HEAD/LINER/SCREWS AND ADDED STEM. COMPLAINT UPDATED 06/03/2016.

N

Patient 1

D

Patient 1

UPDATE 3/31/2017 PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, LAB VALUES WERE PROVIDED THAT CONFIRMED ELEVATED CHROMIUM LEVEL. THE UNKNOWN SCREW IS BEING REJECTED AS ONLY ONE SCREW IMPLANTED.