INSALL-BURNSTEIN TOTAL KNEE SYSTEM UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-06-26 for INSALL-BURNSTEIN TOTAL KNEE SYSTEM UNK manufactured by Zimmer, Inc..

Event Text Entries

[24383] Pt had a left total knee replacement done on 9/14/95 in philadelphia. There is some question as to pt developing a wound infection and wound dehiscence in the post-op period, requiring debridement and skin grafting. It is not clear whether the joint itself was debrided. This info is obtained from the pt, who also notes he was in the hosp for 4 months at the time of his replacement surgery. He also notes that since the time of his second surgical procedure and skin grafting at the left knee, he has had a scab directly over the anterior aspect of the left knee which has intermittently fallen off and drained. Recently, over a period of several days, he had developed painful erthyema and swelling of the left lower extermity. He was admitted to the hosp on 5/9/96 and placed on iv antibiotics and heparin. A c&s of pus from the knee joint grew staph aureus and pseudomonas. Orthopedic consult recommended due to the extensive bone involvement and cellulitis of lower leg, all would indicate poor prognosis for any joint debridement and future attempts to be reimplanted or attempt to fuse knee. On 5/15/96 pt underwent a left above the knee amputation. Findings were infected left total knee replacement with osteomyelitis.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 35714
• MDR Report Key: 35714
• Date Received: 1996-06-26
• Date of Report: 1996-06-26
• Date of Event: 1995-09-14
• Date Added to Maude: 1996-08-23
• 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 Details

• Brand Name: INSALL-BURNSTEIN TOTAL KNEE SYSTEM
• Generic Name: TOTAL KNEE SYSTEM
• Product Code: FWH
• Date Received: 1996-06-26
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 37142
• Manufacturer: ZIMMER, INC.
• Manufacturer Address: PO BOX 708 WARSAW IN 465810708 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1996-06-26