PCA MODULAR KNEE 6628-1-809

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-10-19 for PCA MODULAR KNEE 6628-1-809 manufactured by Howmedica, Inc..

Event Text Entries

[5988] Pt did fine after her total knee until 8/15/94, when she began to dislocate medially. A 16mm constrained insert was replaced in the existing baseplate. 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 evaluated after the event. Method of evaluation: none or unknown. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: yes. Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 33532-1994-00012
• MDR Report Key: 9353
• Date Received: 1994-10-19
• Date of Report: 1994-09-09
• Date of Event: 1994-09-02
• Date Facility Aware: 1994-09-02
• Report Date: 1994-09-09
• Date Reported to FDA: 1994-09-09
• Date Reported to Mfgr: 1994-09-09
• Date Added to Maude: 1994-12-09
• 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 MODULAR KNEE
• Generic Name: TOTAL KNEE
• Product Code: KRN
• Date Received: 1994-10-19
• Catalog Number: 6628-1-809
• Lot Number: TDTPA
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: *
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 9010
• Manufacturer: HOWMEDICA, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1994-10-19