PCA PRIMARY BASEPLATE 6638-3-607

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-22 for PCA PRIMARY BASEPLATE 6638-3-607 manufactured by Howmedica, Inc..

Event Text Entries

[5013] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number33462-1994-01119
MDR Report Key8652
Date Received1994-03-22
Date of Report1994-02-22
Date of Event1994-02-21
Date Facility Aware1994-02-21
Report Date1994-02-22
Date Reported to FDA1994-02-22
Date Reported to Mfgr1994-02-22
Date Added to Maude1994-10-17
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationUNKNOWN
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePCA PRIMARY BASEPLATE
Generic NameTIBIAL PLATEAU INSERT
Product CodeEEA
Date Received1994-03-22
Catalog Number6638-3-607
Lot NumberNA
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityY
Implant FlagY
Device Sequence No1
Device Event Key8316
ManufacturerHOWMEDICA, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1994-03-22

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