ZIMMER *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-03-19 for ZIMMER * manufactured by Zimmer, Inc..

Event Text Entries

[223892] Pt was pulling up with trapeze bar when the trapeze frame bracket broke and struck pt in the head causing a raised area. Although the pt's back was not injured, there was a potential for harm due to diagnosis of lumbar disc herniation.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1021374
• MDR Report Key: 321586
• Date Received: 2001-03-19
• Date of Report: 2001-03-05
• Date of Event: 2001-02-28
• Date Added to Maude: 2001-03-22
• 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
• Reporter Occupation: BIOMEDICAL ENGINEER
• 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: Z-SWING CLAMP - TRAPEZE FRAME BRACKET
• Product Code: HSQ
• Date Received: 2001-03-19
• 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: 311124
• Manufacturer: ZIMMER, INC.
• Manufacturer Address: P.O. BOX 708 WARSAW IN 465810708 US
• Baseline Brand Name: ZIMMER CLAMP ASSEMBLY
• Baseline Generic Name: TRAPEZE CLAMP
• Baseline Catalog No: 00-0640-042-00
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: Y

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2001-03-19