FDA.reportPublic FDA data

MAUDE MDR 6251

MDR report key
6251
Report number
6251
Event key
0
Event type
3
Date of event
1993-07-09
Date received
1993-08-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MILLER/GALANTE POROUS TOTAL KNEE SYSTEM FIBER METALPATELLAR DOME 37MMZIMMERMBD8505-852-3751-49800**

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11993-08-0901. O

Event Narratives#

D

Patient 1

ON 11/17/87 THIS PATIENT HAD A LEFT KNEE ARTHROPLASTY. ON 7/9/93 THIS PATIENT HAD A REVISION OF PATELLAR COMPONENT. THERE WAS CRACKING AND FRAGMENTATION OF THE POLYETHYLENE COMPONENT AND THE METAL BACKING OF THE PATELLA WAS ALSO REMOVEDINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.