MODULAR KNEE JOINT HYDRAULIC 3C11=LR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-02-11 for MODULAR KNEE JOINT HYDRAULIC 3C11=LR manufactured by Otto Bock Health Care.

Event Text Entries

[358060] The pt stood up from breakfast table in a restaurant, the knee did not extend and pt fell and fractured their femur. Hospitalization was necessary to treat the fracture.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2182293-2004-00001
• MDR Report Key: 511181
• Date Received: 2004-02-11
• Date of Report: 2004-02-11
• Date of Event: 2004-01-15
• Date Facility Aware: 2004-01-15
• Report Date: 2004-02-11
• Date Reported to FDA: 2004-02-11
• Date Reported to Mfgr: 2004-02-11
• Date Added to Maude: 2004-02-13
• 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: 3
• Reporter Occupation: RESPIRATORY THERAPIST
• 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: MODULAR KNEE JOINT HYDRAULIC
• Generic Name: PROSTHETIC COMPONENT
• Product Code: ISS
• Date Received: 2004-02-11
• Model Number: 3C11=LR
• Catalog Number: 3C11=LR
• Lot Number: NA
• ID Number: L43346
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: 9 YR
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 500148
• Manufacturer: OTTO BOCK HEALTH CARE
• Manufacturer Address: 14800 28TH AVE. N. PLYMOUTH MN 55447 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2004-02-11