FDA.reportPublic FDA data

MAUDE MDR 8652

MDR report key
8652
Report number
33462-1994-01119
Event key
0
Event type
3
Date of event
1994-02-21
Date received
1994-03-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
999
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
D
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PCA PRIMARY BASEPLATETIBIAL PLATEAU INSERTHOWMEDICA, INC.EEA6638-3-607NAYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11994-03-2201. R

Event Narratives#

D

Patient 1

1) REVISE PREVIOUS REVISION OF PATELLA WITH A PATELLA FROM AN UNKNOWN MFG.2) TIBIA BASEPLATE WAS REMOVED DUE TO POLYETHELYNE WEAAAAR & DILAMINATION.DEVICE LABELED FOR SINGLE USE. 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.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. 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: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.