PCA 32MM STD FEMORAL HEAD 6284-0-132

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-10-14 for PCA 32MM STD FEMORAL HEAD 6284-0-132 manufactured by Howmedica, Inc..

Event Text Entries

[4707] Unknowndevice labeled for single use. Patient medical status prior to event: unknown. 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: unknown (cannot determine). Corrective actions: no data. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	33462-1993-01102
MDR Report Key	7234
Date Received	1993-10-14
Date of Report	1993-09-03
Date of Event	1993-08-17
Report Date	1993-09-03
Date Reported to FDA	1993-09-03
Date Reported to Mfgr	1993-09-03
Date Added to Maude	1994-01-13
Event Key	0
Report Source Code	Distributor report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	0
Reporter Occupation	UNKNOWN
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	PCA 32MM STD FEMORAL HEAD
Generic Name	SAB
Product Code	JDD
Date Received	1993-10-14
Catalog Number	6284-0-132
Operator	OTHER HEALTH CARE PROFESSIONAL
Device Availability	Y
Implant Flag	Y
Device Sequence No	1
Device Event Key	6915
Manufacturer	HOWMEDICA, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-10-14