ZIMMER *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-09-09 for ZIMMER * manufactured by Zimmer, Inc..

Event Text Entries

[15737686] Pt reached up to trapeze, clamp broke, and trapeze fell onto pt. Pt denies injury but spouse states they think pt was struck by falling trapeze. Pt assessed, no visible injury noted. This is the second pt within 18 months that this same part on trapeze has broken. Clamp used is on both ends of double clamp and one end of single clamp bars.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1029470
• MDR Report Key: 484078
• Date Received: 2003-09-09
• Date of Report: 2003-08-18
• Date of Event: 2003-08-14
• Date Added to Maude: 2003-09-23
• Event Key: 0
• Report Source Code: Voluntary 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: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ZIMMER
• Generic Name: S-BAR FOR TRAPEZE FRAME
• Product Code: ILZ
• Date Received: 2003-09-09
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 472965
• Manufacturer: ZIMMER, INC.
• Manufacturer Address: 5040 S.W. GRIFFITH DR, STE 201 800-643-7730 BEAVERTON OR 97005 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-09-09