UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-09-28 for UNKNOWN manufactured by Unknown.

Event Text Entries

[3857] This 25-yr-old female had initial repair of torn ligament left knee in 11/85 at another facility. Anterior cruciate ligament was replaced with an artificial prosthetic. On 9/93, developed torn meniscus left knee. Presented 9/15/93 for arthroscopy and prosthetic ligament noted to have deteriorated. Remenents removed and sent to pathology along with staple. 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. Invalid data - whether device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: end of life - expected. Conclusion: there was no device failure. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: none or unknown. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6660
• MDR Report Key: 6660
• Date Received: 1993-09-28
• Date of Report: 1993-09-21
• Date of Event: 1993-09-15
• Date Facility Aware: 1993-09-16
• Report Date: 1993-09-21
• Date Reported to FDA: 1993-09-21
• Date Added to Maude: 1993-10-06
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• 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: UNKNOWN
• Generic Name: ARTIFICIAL PROSTHETIC LIGAMENT AND STAPLE
• Product Code: LML
• Date Received: 1993-09-28
• Model Number: UNKNOWN
• Catalog Number: UNKNOWN
• Lot Number: UNKNOWN
• ID Number: UNKNOWN
• Device Availability: N
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 6344
• Manufacturer: UNKNOWN

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-09-28