HOWMEDICA AMC TOTAL WRIST * 6440-4-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-11-16 for HOWMEDICA AMC TOTAL WRIST * 6440-4-001 manufactured by Howmedica.

Event Text Entries

[115161] Total wrist implant dislocated on xray 6/12/1998. Implant placed 10/4/1984. Replaced on 7/31/1998.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 198151
• MDR Report Key: 198151
• Date Received: 1998-11-16
• Date of Report: 1998-11-16
• Date of Event: 1998-08-25
• Report Date: 1998-11-16
• Date Reported to FDA: 1998-11-16
• Date Reported to Mfgr: 1998-11-16
• Date Added to Maude: 1998-11-23
• 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: 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 Sequence Number: 1

• Brand Name: HOWMEDICA AMC TOTAL WRIST
• Generic Name: SMALL MODIFIED RADIAL COMPONENT
• Product Code: KWM
• Date Received: 1998-11-16
• Model Number: *
• Catalog Number: 6440-4-001
• Lot Number: VZHL01
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 14 YR
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 192498
• Manufacturer: HOWMEDICA
• Manufacturer Address: 824 S. 75TH OMAHA NE 68114 US

Device Sequence Number: 2

• Brand Name: HOWMEDICA AMC TOTAL WRIST
• Generic Name: STANDARD/SMALL "R" METACARPAL COMPONENT
• Product Code: KWN
• Date Received: 1998-11-16
• Model Number: *
• Catalog Number: 6440-5-002
• Lot Number: KGZ HA
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 2
• Device Event Key: 192501
• Manufacturer: HOWMEDICA
• Manufacturer Address: 824 S. 75TH OMAHA NE 68114 US
• Baseline Brand Name: AMC WRIST
• Baseline Generic Name: ARTIFICIAL WRIST COMPONENT
• Baseline Model No: NA
• Baseline Catalog No: 6440-5-002
• Baseline ID: NA
• Baseline Device Family: METACARPAL SOMPONENT
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K790793
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0		1998-11-16