SCREW DVO DRIVE N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-12-02 for SCREW DVO DRIVE N/A manufactured by Howmedica, Inc..

Event Text Entries

[1075] Tibial component subsided anteriorly. Patella component delaminated. Replaced with stemmed baseplate cemented, revision insert-excellent result. Tibial component to small or no anterior cortical contact. Patella was resected on a 10 degree angle superiorlyinvalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding 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 not used as labeled/indended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number33448-1992-00014
MDR Report Key1901
Date Received1992-12-02
Date of Report1992-11-19
Date of Event1992-11-17
Date Facility Aware1992-11-18
Report Date1992-11-19
Date Reported to FDA1992-11-19
Date Reported to Mfgr1992-11-19
Date Added to Maude1992-12-15
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 NameSCREW DVO DRIVE
Generic NamePCA KNEE
Product CodeLRZ
Date Received1992-12-02
Catalog NumberN/A
Lot NumberN/A
Device Availability*
Implant FlagY
Device Sequence No1
Device Event Key1775
ManufacturerHOWMEDICA, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1992-12-02

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