INFINITY SYSTEM * 2601-2804

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-01-31 for INFINITY SYSTEM * 2601-2804 manufactured by Dow Corning Wright.

Event Text Entries

[21636113] While sitting in a chair at home this pt felt a pop in his hip and experienced severe pain. On x-ray in emergency dept a dislocation of the left hip was confirmed. In surgery 12/6/96 the previously inserted (10/13/94) femoral component was completely disassociated at the stem, trochanteric module junction and the trochanteric module and extra long femoral head were lying free in the soft tissue.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 80409
• MDR Report Key: 80409
• Date Received: 1997-01-31
• Date of Report: 1996-10-08
• Date of Event: 1994-12-03
• Date Added to Maude: 1997-04-03
• 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: INFINITY SYSTEM
• Generic Name: FEMORAL HEAD REPLACEMENT
• Product Code: KWY
• Date Received: 1997-01-31
• Model Number: *
• Catalog Number: 2601-2804
• Lot Number: 113M849230
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 79873
• Manufacturer: DOW CORNING WRIGHT
• Manufacturer Address: 5677 AIRLINE RD. ARLINGTON TN 38002 US

Device Sequence Number: 2

• Brand Name: INFINITY SYSTEM
• Generic Name: FEMORAL HEAD REPLACEMENT
• Product Code: KWY
• Date Received: 1997-01-31
• Model Number: *
• Catalog Number: 1808-0043
• Lot Number: 044M051434
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 79874
• Manufacturer: DOW CORNING WRIGHT
• Manufacturer Address: 5677 AIRLINE RD ARLINGTON TN 38002 US

Device Sequence Number: 3

• Brand Name: INFINITY SYSTEM
• Generic Name: FEMORAL HEAD REPLACEMENT
• Product Code: KWB
• Date Received: 1997-01-31
• Model Number: *
• Catalog Number: 1808-0158
• Lot Number: 103M915570
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 79877
• Manufacturer: DOW CORNING WRIGHT
• Manufacturer Address: 5677 AIRLINE RD ARLINGTON TN 38002 US

Device Sequence Number: 4

• Brand Name: INFINITY SYSTEM
• Generic Name: FEMORAL HEAD REPLACEMENT
• Product Code: HXO
• Date Received: 1997-01-31
• Model Number: *
• Catalog Number: 2002-0039
• Lot Number: 093M878720
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 4
• Device Event Key: 79881
• Manufacturer: DOW CORNING WRIGHT
• Manufacturer Address: 5677 AIRLINE RD ARLINGTON TN 38002 US

Device Sequence Number: 5

• Brand Name: INFINITY SYSTEM
• Generic Name: FEMORAL HEAD REPLACEMENT
• Product Code: KWY
• Date Received: 1997-01-31
• Model Number: *
• Catalog Number: 1808-0063
• Lot Number: 072M715980
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 5
• Device Event Key: 79883
• Manufacturer: DOW CORNING WRIGHT
• Manufacturer Address: 5677 AIRLINE RD ARLINGTON TN 38002 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	1997-01-31