FDA.reportPublic FDA data

MAUDE MDR 5251460

MDR report key
5251460
Report number
1818910-2015-35994
Event key
0
Event type
3
Date of event
2015-08-07
Date received
2015-11-25
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
1UNKNOWN DEPUY CEMENTKNEE OTHER IMPLANT9610921 DEPUY CMWKWHUNK-KNEEUNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-11-2501. R

Event Narratives#

N

Patient 1

UDI: UNAVAILABLE. 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) FOR THE ATTUNE PS FEM LT SZ9 CEM AND THE ATTUNE FB TIB BASE SZ8 CEM 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. DR-002788 HAS BEEN UNDERTAKEN TO INVESTIGATE FURTHER. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

D

Patient 1

THE PATIENT WAS REVISED TO ADDRESS CONCERNS OF A LOOSENING AND PAIN. UPON REVISION THE PATIENT'S PATELLA WAS WELL FIXED AND HAD NO WEAR. THE TIBIAL AND FEMORAL COMPONENTS WERE REVISED AND REPLACED. THE REVISION OPERATIVE NOTE INDICATED IN THE PRE AND POST OP DIAGNOSIS IT WAS A LOOSE/FAILED LEFT TKA BUT DID NOT SPECIFY WHICH COMPONENTS WERE LOOSE. AT THIS TIME IT IS UNKNOWN IF DEPUY CEMENT WAS USED. UPDATE REC'D 11/13/2015 - THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. UPDATE REC'D 11/13/2015 - THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT HAD DEPUY CEMENT WAS IMPLANTED ON (B)(6) 2014. AT THIS TIME THE DEPUY CEMENT IS BEING REPORTED AND THE LOT INFORMATION IS BEING UPDATED FOR THE FEMORAL COMPONENT AND TRAY. THE COMPLAINT WAS UPDATED ON: 11/25/2015.

N

Patient 1

DEPUY STILL 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.