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 Number: 33462-1994-01119
• MDR Report Key: 8652
• Date Received: 1994-03-22
• Date of Report: 1994-02-22
• Date of Event: 1994-02-21
• Date Facility Aware: 1994-02-21
• Report Date: 1994-02-22
• Date Reported to FDA: 1994-02-22
• Date Reported to Mfgr: 1994-02-22
• Date Added to Maude: 1994-10-17
• 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 PRIMARY BASEPLATE
• Generic Name: TIBIAL PLATEAU INSERT
• Product Code: EEA
• Date Received: 1994-03-22
• Catalog Number: 6638-3-607
• Lot Number: NA
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 8316
• Manufacturer: HOWMEDICA, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1994-03-22