UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-16 for UNKNOWN manufactured by Unknown.

Event Text Entries

[4524] Pt admitted with septic arthritis of total knee replacement had tkr in 11/91 at another facility. Developed septic joint during "winter" of 1992 per md history. Diagnosis of septic knee made in jan 1993. Out pt treatment with iv antibiotics and debreidement of joint area at another facility in feb 1993. Treatment appeared successful, then recurred initiating admission at this facility on 6/28/93 for iv antibiotic therapy and evaluation. Device continued in place no loosening of joint noted. Invalid data - regarding single use labeling of device. 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, other. Results of evaluation: anticipated or known, inherent risk of procedure. Conclusion: there was no device failure, none or unknown. Certainty of device as cause of or contributor to event: invalid data. 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: 6330
• MDR Report Key: 6330
• Date Received: 1993-08-16
• Date of Event: 1993-06-28
• Date Facility Aware: 1993-07-07
• Date Added to Maude: 1993-08-31
• 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: TOTAL KNEE PROSTHESIS
• Product Code: KMB
• Date Received: 1993-08-16
• 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: 6019
• Manufacturer: UNKNOWN

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-08-16